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Article ; Online: Diagnosis and Acute Management of E-Cigarette or Vaping Product Use-Associated Lung Injury in the Pediatric Population: A Systematic Review.

Gonsalves, Clarelle L / Zhu, Jie Wei / Kam, April J

2020 Volume 228, Page(s) 260–270

Abstract: ... in the acute care setting.: Study design: A literature search using keywords was performed on April 17, 2020 ...

Abstract	Objective: To assess quantitative data on the presentation, investigative findings, patterns of lung injury, and interventions of pediatric cases of e-cigarette or vaping-associated lung injury (EVALI) in the acute care setting. Study design: A literature search using keywords was performed on April 17, 2020, in accordance with PRISMA guidelines. Three thousand five hundred fifty-eight articles were retrieved from MEDLINE via PubMed, Embase via OVID, CINAHL via EBSCO, Web of Science, and the Cochrane Library. Studies were evaluated for inclusion based on predetermined inclusion and exclusion criteria by 2 independent reviewers. Results: The search yielded a total of 3558 individual results, 145 of which were evaluated by full text review, resulting in 23 articles included in this systematic review. Two of these articles were identified by manual search of article references. A total of 61 cases of EVALI were described, and 10 major patterns of lung injury were identified for which presenting symptoms, diagnostic and laboratory investigations, interventions, and outcomes were synthesized. Conclusions: Cases of EVALI in the pediatric population have been reported in patients as young as 13 years and often present with respiratory, constitutional, abdominal, and cardiovascular signs and symptoms. Diagnostic findings vary based on the underlying lung injury pattern. However, typical patterns of common findings were identified, including the presence of ground-glass opacities on computed tomography scan and leukocytosis. Mainstays of treatment include the use of corticosteroids, antibiotics, and ventilatory support, including extracorporeal membrane oxygenation. Outcomes range from complete or near complete recovery of lung function to death.
MeSH term(s)	Child ; Electronic Nicotine Delivery Systems ; Global Health ; Humans ; Lung Injury/diagnosis ; Lung Injury/epidemiology ; Lung Injury/therapy ; Population Surveillance/methods ; Tomography, X-Ray Computed ; Vaping/adverse effects
Language	English
Publishing date	2020-09-19
Publishing country	United States
Document type	Journal Article ; Systematic Review
ZDB-ID	3102-1
ISSN	1097-6833 ; 0022-3476
ISSN (online)	1097-6833
ISSN	0022-3476
DOI	10.1016/j.jpeds.2020.09.040
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Article: Osimertinib is associated with improved outcomes in pre-treated non-small cell lung cancer leptomeningeal metastases: A systematic review and meta-analysiss.

Bian, David J H / Lazaratos, Anna-Maria / Maritan, Sarah M / Quaiattini, Andrea / Zeng, Zhimin / Zhu, Zhengfei / Sener, Ugur / Malani, Rachna / Kim, Yu Jung / Ichihara, Eiki / Cohen, Victor / Rose, April A N / Bouganim, Nathaniel / Dankner, Matthew

Heliyon

2024 Volume 10, Issue 9, Page(s) e29668

Abstract: Purpose: Leptomeningeal metastasis (LM) is a severe complication of non-small cell lung cancer (NSCLC). In patients with NSCLC LM harboring epidermal growth factor receptor (: Methods: This systematic review and meta-analysis performed according to ... ...

Abstract	Purpose: Leptomeningeal metastasis (LM) is a severe complication of non-small cell lung cancer (NSCLC). In patients with NSCLC LM harboring epidermal growth factor receptor ( Methods: This systematic review and meta-analysis performed according to PRISMA guidelines included studies of adult patients with Results: 128 publications were included with 243 patients and 282 lines of EGFR-TKI for NSCLC LM that met inclusion criteria. The median PFS in patients receiving any EGFR-TKI was 9.1 months, and the median OS was 14.5 months. In univariate analyses of the entire cohort, osimertinib treatment demonstrated significantly prolonged PFS, but not OS, compared to other EGFR-TKIs. Osimertinib demonstrated significantly prolonged PFS and OS in the subset of patients who were previously treated with EGFR-TKIs, but not in EGFR-TKI naïve patients. Conclusion: Osimertinib is associated with improved outcomes compared to other EGFR-TKIs, particularly in patients previously treated with EGFR-TKIs. An important limitation is that most patients were derived from retrospective reports. These results highlight the need for prospective studies for this difficult-to-treat patient population.
Language	English
Publishing date	2024-04-17
Publishing country	England
Document type	Journal Article
ZDB-ID	2835763-2
ISSN	2405-8440
ISSN	2405-8440
DOI	10.1016/j.heliyon.2024.e29668
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Article ; Online: Diagnosis and Acute Management of Adolescent Cannabinoid Hyperemesis Syndrome: A Systematic Review.

Zhu, Jie Wei / Gonsalves, Clarelle L / Issenman, Robert M / Kam, April J

The Journal of adolescent health : official publication of the Society for Adolescent Medicine

2020 Volume 68, Issue 2, Page(s) 246–254

Abstract: Purpose: This study aimed to synthesize qualitative and quantitative data on the diagnosis and effective management of cannabinoid hyperemesis syndrome (CHS) in the adolescent population.: Methods: Using keywords, 1,334 studies published between ... ...

Abstract	Purpose: This study aimed to synthesize qualitative and quantitative data on the diagnosis and effective management of cannabinoid hyperemesis syndrome (CHS) in the adolescent population. Methods: Using keywords, 1,334 studies published between December 1954 and December 2019 were extracted from MEDLINE via PubMed, Embase via OVID, CINAHL via EBSCO, Web of Science, and the Cochrane Library. Studies were evaluated by two independent reviewers using predetermined inclusion and exclusion criteria. Results: The search yielded 148 studies for full-text review, of which 21 were included in this systematic review. A total of 10 articles were related to the diagnosis of CHS, while 11 articles discussed the treatment and management of adolescent cases of CHS. Conclusions: CHS in the adolescent population fulfills the major and minor diagnostic criteria of CHS in the adult population; however, in adolescent patients, CHS may present more frequently in females, with the earliest reported case presenting at age 15 years. There appears to be a substantial proportion (21%) of adolescent patients diagnosed with CHS that have a history of anxiety and depression; however, higher quality studies to assess the prevalence are warranted. Although haloperidol and topical capsaicin cream may provide symptom relief in isolated cases, complete cessation of cannabis use is currently the only known effective treatment.
MeSH term(s)	Adolescent ; Adult ; Cannabinoids/adverse effects ; Capsaicin ; Female ; Humans ; Marijuana Abuse/diagnosis ; Marijuana Abuse/therapy ; Syndrome ; Treatment Outcome ; Vomiting/chemically induced ; Vomiting/diagnosis ; Vomiting/therapy
Chemical Substances	Cannabinoids ; Capsaicin (S07O44R1ZM)
Language	English
Publishing date	2020-10-07
Publishing country	United States
Document type	Journal Article ; Review ; Systematic Review
ZDB-ID	1063374-1
ISSN	1879-1972 ; 1054-139X
ISSN (online)	1879-1972
ISSN	1054-139X
DOI	10.1016/j.jadohealth.2020.07.035
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Article: Surgical versus conservative management of tongue lacerations in the acute care setting: A systematic review of the literature.

Gonsalves, Clarelle L / Zhu, Jie Wei / Kim, Grace Y / Leveille, Cameron F / Kam, April J

Paediatrics & child health

2021 Volume 27, Issue 1, Page(s) 32–42

Abstract: Objective: The objective of this study was to determine whether suturing or conservative management of tongue lacerations results in differences in wound healing and functional outcome. The secondary aim was to identify whether antibiotics are required ... ...

Abstract	Objective: The objective of this study was to determine whether suturing or conservative management of tongue lacerations results in differences in wound healing and functional outcome. The secondary aim was to identify whether antibiotics are required in the treatment of tongue lacerations. Methods: Studies published between December 1954 and August 2020 were extracted from MEDLINE via PubMed, Embase via OVID, CINAHL via EBSCO, Web of Science, and the Cochrane Library and evaluated for inclusion based on predetermined inclusion and exclusion criteria by two independent reviewers in accordance with PRISMA guidelines. Results: The search yielded a total of 16,111 articles, 124 of which were evaluated by full-text review, resulting in 11 articles included in this systematic review representing 142 unique cases of tongue lacerations. At least 26 lacerations (18.3%) included penetration of the muscle layer of the tongue, and 24 (16.9%) were classified as full-thickness lacerations. Thirty-five of the 142 tongue lacerations (24.6%) were sutured. The remaining lacerations underwent some form of conservative management. The majority of studies reported excellent healing of tongue lacerations regardless of the management method, with minimal scarring and excellent return to normal functional status. No cases of infection were reported. Conclusions: Current literature is inconsistent with regards to indications and guidelines for primary repair of tongue lacerations. The majority of tongue lacerations reported in the literature heal with excellent outcomes regardless of management method. Physician judgement along with patient and parental preference based on potential risks of the procedure should be used when deciding whether a tongue laceration requires primary repair. Tongue lacerations in otherwise healthy individuals are at very low risk of infection.
Language	English
Publishing date	2021-08-03
Publishing country	England
Document type	Journal Article
ZDB-ID	2106767-3
ISSN	1918-1485 ; 1205-7088
ISSN (online)	1918-1485
ISSN	1205-7088
DOI	10.1093/pch/pxab044
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Article ; Online: Treatment Goals for Psoriasis as Measured by Patient Benefit Index: Results of a National Psoriasis Foundation Survey.

Armstrong, April / Edson-Heredia, Emily / Zhu, Baojin / Burge, Russel / Bell, Stacie / Crowley, Jeffery J / Smith, Stacy

Advances in therapy

2022 Volume 39, Issue 6, Page(s) 2657–2667

Abstract: Introduction: This cross-sectional survey was conducted with National Psoriasis Foundation (NPF) to capture treatment perspectives and expectations in patients with psoriasis (PsO) using Patient Needs Questionnaire (PNQ) of Patient Benefit Index (PBI).!# ...

Abstract	Introduction: This cross-sectional survey was conducted with National Psoriasis Foundation (NPF) to capture treatment perspectives and expectations in patients with psoriasis (PsO) using Patient Needs Questionnaire (PNQ) of Patient Benefit Index (PBI). Methods: Adult participants with self-reported diagnosis of PsO responded to the PNQ portion of PBI by indicating how much they valued different treatment attributes. All the treatment goals were captured on a five-point Likert scale (0 = "Not important", 4 = "Very important"). Treatment goals were obtained for overall population and subgroups based on severity of disease Patient Global Assessment (PGA), age, gender, and Dermatology Life Quality Index (DLQI) total score. All data were expressed as mean and standard deviation [SD]. Results: A total of 1200 participants completed the survey (mean age 51.5 years). Top treatment goal in the overall population was "to have confidence in the therapy" (3.46 [1.01]). Unique to the higher severity subgroup (PGA ≥ 3), "to find a clear diagnosis and therapy" was a top five goal and "to get better skin quickly" was for those with lesser severity (PGA < 3). "To be free of itching" (3.36 [0.99]) was the unique goal in the < 40 age group whereas it was "to get better skin quickly" (3.27 [1.12]) in the ≥ 40 group. In women and men, "to be free of itching" (3.38 [1.13]) and "to get better skin quickly" (3.20 [1.09]) were top five goals, respectively. Patients with ≥ 10 DLQI scores expressed higher treatment goal "to regain control of the disease" (3.66 [0.67]) compared to those with ≤ 10 DLQI scores who expressed "to have confidence in the therapy" (3.40 [1.11]) as the topmost treatment goal. Conclusion: Our results suggest that in patients with PsO, treatment preferences can vary with different characteristics such as age, severity, and gender as measured by using PNQ. Further exploration of this data will help inform treatment decisions and optimize patient outcomes.
MeSH term(s)	Adult ; Cross-Sectional Studies ; Female ; Goals ; Humans ; Male ; Middle Aged ; Prostaglandins A ; Pruritus ; Psoriasis/diagnosis ; Psoriasis/drug therapy ; Quality of Life ; Severity of Illness Index ; Treatment Outcome
Chemical Substances	Prostaglandins A
Language	English
Publishing date	2022-04-11
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	632651-1
ISSN	1865-8652 ; 0741-238X
ISSN (online)	1865-8652
ISSN	0741-238X
DOI	10.1007/s12325-022-02124-2
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Zs.A 2101: Show issues

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Article ; Online: Vaping identity in adolescent e-cigarette users: A comparison of norms, attitudes, and behaviors.

Donaldson, Candice D / Fecho, Cassandra L / Ta, Tiffany / Vuong, Tam D / Zhang, Xueying / Williams, Rebecca J / Roeseler, April G / Zhu, Shu-Hong

Drug and alcohol dependence

2021 Volume 223, Page(s) 108712

Abstract: Introduction: Using the tenets underlying social identity theory and the theory of planned behavior, the current study compared the perceptions, attitudes, and behaviors of e-cigarette users that reported vaping as self-defining ("vapers") compared to ... ...

Abstract	Introduction: Using the tenets underlying social identity theory and the theory of planned behavior, the current study compared the perceptions, attitudes, and behaviors of e-cigarette users that reported vaping as self-defining ("vapers") compared to users that denied vaping was central to their identity ("non-vapers"). Method: Secondary analyses of data from the 2017-2018 California Student Tobacco Survey were utilized. A weighted, multivariable regression model (N = 82,217) compared the demographic characteristics, beliefs, and behaviors of vapers and non-vapers. A path analytic model examined whether norms and attitudes mediated the relationship between vaper identity and use behavior. Results: Self-identified sexual and/or gender minority youth were more likely to identify as vapers compared to heterosexual and cisgender respondents. Youth that identified as vapers viewed e-cigarette use as more normative, held more favorable attitudes (i.e., lower harm beliefs), used e-cigarettes more frequently and in greater quantities, were more likely to use fruit and mint flavored e-cigarettes, and were more likely to acquire e-cigarettes from commercial sellers (i.e., vape/tobacco shops; all p < 0.05). Additionally, descriptive norms and attitudes mediated the relationship between vaper identity and use frequency/quantity. Conclusions: Differences in e-cigarette beliefs and behaviors were found for youth e-cigarette users that perceived vaping as self-defining versus those that did not view vaping as part of their self-concept. Future studies are needed to examine causal directionality between identity, norms, attitudes, and behavior. Tobacco control efforts might use these findings to further denormalize vaping using evidence-based media campaigns and policy implementation.
MeSH term(s)	Adolescent ; Attitude ; Electronic Nicotine Delivery Systems ; Humans ; Smokers ; Surveys and Questionnaires ; Tobacco Products ; Vaping
Language	English
Publishing date	2021-04-20
Publishing country	Ireland
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	519918-9
ISSN	1879-0046 ; 0376-8716
ISSN (online)	1879-0046
ISSN	0376-8716
DOI	10.1016/j.drugalcdep.2021.108712
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Article ; Online: Elevated depressive symptoms and risk of all-cause and cardiovascular mortality among adults with and without diabetes: The REasons for Geographic And Racial Differences in Stroke (REGARDS) study.

Liwo, Amandiy N N / Howard, Virginia J / Zhu, Sha / Martin, Michelle Y / Safford, Monika M / Richman, Joshua S / Cummings, Doyle M / Carson, April P

Journal of diabetes and its complications

2020 Volume 34, Issue 10, Page(s) 107672

Abstract: Aims: To examine the association of elevated depressive symptoms with all-cause and cardiovascular disease (CVD) mortality and determine whether these associations differ for those with and without diabetes.: Methods: We included 22,807 black and ... ...

Abstract	Aims: To examine the association of elevated depressive symptoms with all-cause and cardiovascular disease (CVD) mortality and determine whether these associations differ for those with and without diabetes. Methods: We included 22,807 black and white men and women aged 45-98 years at baseline (2003-2007) from the REasons for Geographic And Racial Differences in Stroke (REGARDS) Study. Elevated depressive symptoms were defined as a score ≥ 4 on the 4-item Centers for Epidemiologic Studies of Depression Scale. Participants were classified as having diabetes, prediabetes, or no prediabetes/diabetes based on glucose levels and diabetes medication use. All-cause mortality events were available through 2018 and adjudicated CVD mortality events were available through 2015. Results: During follow-up, there were 5383 all-cause deaths, of which 1585 were adjudicated CVD deaths. The mean survival time was lower for participants with elevated depressive symptoms than those without elevated depressive symptoms for those with diabetes, prediabetes, and no prediabetes/diabetes. In multivariable adjusted models, elevated depressive symptoms increased the risk of all-cause mortality for those with diabetes (HR = 1.15; 95% CI = 1.00-1.32), prediabetes (HR = 1.56; 95% CI = 1.28-1.91), and neither prediabetes/diabetes (HR = 1.34; 95% CI = 1.19-1.50) (p for interaction = 0.0342). Findings were similar for CVD mortality. Conclusion: Elevated depressive symptoms increased the risk of all-cause and CVD mortality among individuals with and without diabetes, with a stronger magnitude of association observed among those with prediabetes. This underscores the need for assessing depressive symptoms across the glycemic spectrum, including those with prediabetes.
MeSH term(s)	Adult ; African Americans/psychology ; African Americans/statistics & numerical data ; Aged ; Aged, 80 and over ; Cardiovascular Diseases/ethnology ; Cardiovascular Diseases/mortality ; Cardiovascular Diseases/psychology ; Cause of Death ; Depression/epidemiology ; Diabetes Complications/complications ; Diabetes Complications/mortality ; Diabetes Complications/psychology ; European Continental Ancestry Group/psychology ; European Continental Ancestry Group/statistics & numerical data ; Female ; Humans ; Male ; Middle Aged ; Proportional Hazards Models ; Risk Factors ; Survival Rate
Language	English
Publishing date	2020-07-06
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	1105840-7
ISSN	1873-460X ; 1056-8727
ISSN (online)	1873-460X
ISSN	1056-8727
DOI	10.1016/j.jdiacomp.2020.107672
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Zs.A 2225: Show issues

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Article ; Online: High transferrin saturation predicts inferior clinical outcomes in patients with myelodysplastic syndromes.

Teichman, Jennifer / Geddes, Michelle / Zhu, Nancy / Keating, Mary-Margaret / Sabloff, Mitchell / Christou, Grace / Leber, Brian / Khalaf, Dina / St-Hilaire, Eve / Finn, Nicholas / Shamy, April / Yee, Karen W L / Storring, John M / Nevill, Thomas J / Delage, Robert / Elemary, Mohamed / Banerji, Versha / Houston, Brett / Mozessohn, Lee /

Chodirker, Lisa / Zhang, Liying / Siddiqui, Mohammed / Parmentier, Anne / Leitch, Heather A / Buckstein, Rena J

Haematologica

2023 Volume 108, Issue 2, Page(s) 532–542

Abstract: Iron overload (IO) reflected by elevated ferritin is associated with increased mortality in myelodysplastic syndromes (MDS), however, ferritin is an imperfect metric. Elevated labile plasma iron correlates with clinical outcomes and transferrin ... ...

Abstract	Iron overload (IO) reflected by elevated ferritin is associated with increased mortality in myelodysplastic syndromes (MDS), however, ferritin is an imperfect metric. Elevated labile plasma iron correlates with clinical outcomes and transferrin saturation (TSAT) >80%, but is not readily measurable. The trajectory of TSAT, and its association with clinical outcomes remain undefined. Canadian MDS registry patients were evaluated. Mean TSAT, mean ferritin and transfusion dose density (TDD) were determined. Survival was evaluated by TSAT and ferritin (<50%, 50-80%, >80%), (≤500 μg/L, 501-800 μg/L, >800 μg/L). In 718 patients, median age was 74 years; 12%, 31%, 29%, 15% and 13% were IPSS-R very low, low, intermediate, high and very high. TSAT and ferritin were moderately correlated (r=0.63, P<0.0001). TSAT increased over time in transfusion- dependent patients (P=0.006). Higher TSAT and ferritin were associated with inferior 5-year overall (OS), progression- free (PFS), and leukemia-free survival (LFS) (P≤0.008) and higher TDD with inferior 5-year OS. TSAT >80% trended with inferior cardiac death-free survival (P=0.053). In univariate analysis, age, IPSS-R, blast percentage by Eastern Cooperative Oncology Group Performance Status, frailty, Charlson Comorbidity Index, iron chelation (Y/N), TDD, TSAT and ferritin were significantly associated with inferior OS. By multivariable analysis, TSAT >80% (P=0.007) remained significant for OS (R2 30.3%). In MDS, TSAT >80% and ferritin >800 μg/L portended inferior OS, PFS and LFS. TSAT may indicate the presence of oxidative stress, and is readily measurable in a clinical setting. The relationship between TSAT and cardiac death-free survival warrants further study.
MeSH term(s)	Humans ; Aged ; Canada ; Iron ; Ferritins ; Myelodysplastic Syndromes/diagnosis ; Myelodysplastic Syndromes/therapy ; Transferrins ; Transferrin
Chemical Substances	Iron (E1UOL152H7) ; Ferritins (9007-73-2) ; Transferrins ; Transferrin
Language	English
Publishing date	2023-02-01
Publishing country	Italy
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2022.280723
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Article ; Online: Regional and rural-urban patterns in the prevalence of diagnosed hypertension among older U.S. adults with diabetes, 2005-2017.

Uddin, Jalal / Zhu, Sha / Malla, Gargya / Levitan, Emily B / Rolka, Deborah B / Carson, April P / Long, D Leann

BMC public health

2024 Volume 24, Issue 1, Page(s) 1326

Abstract: Background: Hypertension prevalence among the overall US adult population has been relatively stable during the last two decades. However, whether this stabilization has occurred across rural-urban communities and across different geographic regions is ... ...

Abstract	Background: Hypertension prevalence among the overall US adult population has been relatively stable during the last two decades. However, whether this stabilization has occurred across rural-urban communities and across different geographic regions is unknown, particularly among older adults with diabetes who are likely to have concomitant cardiovascular risk factors. Methods: This serial cross-sectional analysis used the 5% national sample of Medicare administrative claims data (n = 3,516,541) to examine temporal trends (2005-2017) in diagnosed hypertension among older adults with diabetes, across urban-rural communities and US census regions (Northeast, Midwest, South, and West). Joinpoint regression was used to obtain annual percent change (APC) in hypertension prevalence across rural-urban communities and geographic regions, and multivariable adjusted regression was used to assess associations between rural-urban communities and hypertension prevalence. Results: The APC in the prevalence of hypertension was higher during 2005-2010, and there was a slowdown in the increase during 2011-2017 across all regions, with significant variations across rural-urban communities within each of the regions. In the regression analysis, in the adjusted model, older adults living in non-core (most rural) areas in the Midwest (PR = 0.988, 95% CI: 0.981-0.995) and West (PR = 0.935, 95% CI: 0.923-0.946) had lower hypertension prevalence than their regional counterparts living in large central metro areas. Conclusions: Although the magnitudes of these associations are small, differences in hypertension prevalence across rural-urban areas and geographic regions may have implications for targeted interventions to improve chronic disease prevention and management.
MeSH term(s)	Humans ; Hypertension/epidemiology ; Aged ; Male ; Female ; Prevalence ; Cross-Sectional Studies ; United States/epidemiology ; Diabetes Mellitus/epidemiology ; Rural Population/statistics & numerical data ; Aged, 80 and over ; Urban Population/statistics & numerical data ; Medicare/statistics & numerical data ; Risk Factors
Language	English
Publishing date	2024-05-16
Publishing country	England
Document type	Journal Article
ZDB-ID	2041338-5
ISSN	1471-2458 ; 1471-2458
ISSN (online)	1471-2458
ISSN	1471-2458
DOI	10.1186/s12889-024-18802-5
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Article ; Online: Randomized, Placebo-Controlled Trial of Targeting Neuroinflammation with Ibudilast to Treat Methamphetamine Use Disorder.

Heinzerling, Keith G / Briones, Marisa / Thames, April D / Hinkin, Charles H / Zhu, Tianle / Wu, Ying Nian / Shoptaw, Steven J

Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology

2019 Volume 15, Issue 2, Page(s) 238–248

Abstract: Methamphetamine (MA) triggers neuroinflammation and medications that counteract MA-induced neuroinflammation may reduce MA-induced neurodegeneration and improve neurocognition and treatment outcomes in MA use disorder. We performed a randomized, placebo- ... ...

Abstract	Methamphetamine (MA) triggers neuroinflammation and medications that counteract MA-induced neuroinflammation may reduce MA-induced neurodegeneration and improve neurocognition and treatment outcomes in MA use disorder. We performed a randomized, placebo-controlled trial to determine the safety and efficacy of ibudilast (IBUD), a phosphodiesterase inhibitor that reduces neuroinflammation, for the treatment of MA use disorder. Treatment-seeking volunteers with MA use disorder were randomly assigned to receive 12 weeks of IBUD 50 mg twice daily (N = 64) or placebo (N = 61) with medication management counseling. Participants visited the outpatient research clinic twice weekly to provide urine specimens for drug screens and undergo study assessments. The primary outcome was end of treatment MA-abstinence (EOTA) during weeks 11 and 12 of treatment. Serum IBUID levels were measured for IBUD participants during week 3 of treatment. There was no difference in EOTA for IBUD (14%) versus placebo (16%, p > 0.05). There was no correlation between serum IBUD levels and MA use during treatment and mean IBUD levels for participants with (mean = 51.3, SD = 20.3) and without (mean = 54.7, SD = 33.0, p = 0.70) EOTA. IBUD was well tolerated. IBUD did not facilitate MA abstinence in this outpatient trial. Whether targeting neuroinflammation, either with IBUD in other subgroups of MA users or clinical trial designs, or with other anti-inflammatory medications, is an effective strategy for treating MA use disorder is not clear. Graphical Abstract The proportion of urine drug screens negative for methamphetamine (MA) during the two week lead-in period (weeks -2 and - 1) and the 12 week medication treatment period (weeks 1-12) for ibudilast versus placebo.
MeSH term(s)	Adult ; Amphetamine-Related Disorders/diagnosis ; Amphetamine-Related Disorders/drug therapy ; Amphetamine-Related Disorders/metabolism ; Central Nervous System Stimulants/adverse effects ; Double-Blind Method ; Female ; Humans ; Inflammation Mediators/antagonists & inhibitors ; Inflammation Mediators/metabolism ; Male ; Methamphetamine/adverse effects ; Middle Aged ; Phosphodiesterase Inhibitors/therapeutic use ; Pyridines/therapeutic use ; Treatment Outcome
Chemical Substances	Central Nervous System Stimulants ; Inflammation Mediators ; Phosphodiesterase Inhibitors ; Pyridines ; Methamphetamine (44RAL3456C) ; ibudilast (M0TTH61XC5)
Language	English
Publishing date	2019-12-09
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	2227405-4
ISSN	1557-1904 ; 1557-1890
ISSN (online)	1557-1904
ISSN	1557-1890
DOI	10.1007/s11481-019-09883-w
Database	MEDical Literature Analysis and Retrieval System OnLINE

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