دورية أكاديمية
A gender-based secondary analysis of the ADAPT-2 combination naltrexone and bupropion treatment for methamphetamine use disorder trial.
العنوان: | A gender-based secondary analysis of the ADAPT-2 combination naltrexone and bupropion treatment for methamphetamine use disorder trial. |
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المؤلفون: | Levander XA; Oregon Health and Science University, Department of Medicine, Division of General Internal Medicine and Geriatrics, Addiction Medicine Section, Portland, OR, USA., Carmody T; Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX, USA., Cook RR; Oregon Health and Science University, Department of Medicine, Division of General Internal Medicine and Geriatrics, Addiction Medicine Section, Portland, OR, USA., Potter JS; Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center San Antonio, San Antonio, TX, USA., Trivedi MH; Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA., Korthuis PT; Oregon Health and Science University, Department of Medicine, Division of General Internal Medicine and Geriatrics, Addiction Medicine Section, Portland, OR, USA., Shoptaw S; Department of Family Medicine, University of California Los Angeles, Los Angeles, CA, USA.; Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, Los Angeles, CA, USA. |
المصدر: | Addiction (Abingdon, England) [Addiction] 2023 Jul; Vol. 118 (7), pp. 1320-1328. Date of Electronic Publication: 2023 Mar 02. |
نوع المنشور: | Randomized Controlled Trial; Multicenter Study; Journal Article; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S. |
اللغة: | English |
بيانات الدورية: | Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 9304118 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1360-0443 (Electronic) Linking ISSN: 09652140 NLM ISO Abbreviation: Addiction Subsets: MEDLINE |
أسماء مطبوعة: | Publication: Oxford : Wiley-Blackwell Original Publication: Abingdon, Oxfordshire, UK : Carfax Pub. Co., c1993- |
مواضيع طبية MeSH: | Methamphetamine* , Central Nervous System Stimulants*/therapeutic use, Male ; Pregnancy ; Humans ; Female ; Adult ; Naltrexone ; Bupropion/therapeutic use ; Drug Therapy, Combination ; Double-Blind Method |
مستخلص: | Background and Aims: Socio-cultural (gender) and biological (sex)-based differences contribute to psychostimulant susceptibility, potentially affecting treatment responsiveness among women with methamphetamine use disorder (MUD). The aims were to measure (i) how women with MUD independently and compared with men respond to treatment versus placebo and (ii) among women, how the hormonal method of contraception (HMC) affects treatment responsiveness. Design: This was a secondary analysis of ADAPT-2, a randomized, double-blind, placebo-controlled, multicenter, two-stage sequential parallel comparison design trial. Setting: United States. Participants: This study comprised 126 women (403 total participants); average age = 40.1 years (standard deviation = 9.6) with moderate to severe MUD. Interventions: Interventions were combination intramuscular naltrexone (380 mg/3 weeks) and oral bupropion (450 mg daily) versus placebo. Measurements: Treatment response was measured using a minimum of three of four negative methamphetamine urine drug tests during the last 2 weeks of each stage; treatment effect was the difference between weighted treatment responses of each stage. Findings: At baseline, women used methamphetamine intravenously fewer days than men [15.4 versus 23.1% days, P = 0.050, difference = -7.7, 95% confidence interval (CI) = -15.0 to -0.3] and more women than men had anxiety (59.5 versus 47.6%, P = 0.027, difference = 11.9%, 95% CI = 1.5 to 22.3%). Of 113 (89.7%) women capable of pregnancy, 31 (27.4%) used HMC. In Stage 1 29% and Stage 2 5.6% of women on treatment had a response compared with 3.2% and 0% on placebo, respectively. A treatment effect was found independently for females and males (P < 0.001); with no between-gender treatment effect (0.144 females versus 0.100 males; P = 0.363, difference = 0.044, 95% CI = -0.050 to 0.137). Treatment effect did not differ by HMC use (0.156 HMC versus 0.128 none; P = 0.769, difference = 0.028, 95% CI -0.157 to 0.212). Conclusions: Women with methamphetamine use disorder receiving combined intramuscular naltrexone and oral bupropion treatment achieve greater treatment response than placebo. Treatment effect does not differ by HMC. (© 2023 Society for the Study of Addiction.) |
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معلومات مُعتمدة: | UG1 DA020024 United States DA NIDA NIH HHS; K01 DA055130 United States DA NIDA NIH HHS; UG1 DA015815 United States DA NIDA NIH HHS; K12 HS026370 United States HS AHRQ HHS; HHSN271201400028C United States DA NIDA NIH HHS; HHSN271201500065C United States DA NIDA NIH HHS |
فهرسة مساهمة: | Keywords: Amphetamine-related disorders; bupropion; clinical trial; gender differences; methamphetamine; naltrexone; sex differences; women; women's health |
المشرفين على المادة: | 44RAL3456C (Methamphetamine) 5S6W795CQM (Naltrexone) 01ZG3TPX31 (Bupropion) 0 (Central Nervous System Stimulants) |
تواريخ الأحداث: | Date Created: 20230302 Date Completed: 20230614 Latest Revision: 20240702 |
رمز التحديث: | 20240702 |
مُعرف محوري في PubMed: | PMC10330044 |
DOI: | 10.1111/add.16163 |
PMID: | 36864016 |
قاعدة البيانات: | MEDLINE |
تدمد: | 1360-0443 |
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DOI: | 10.1111/add.16163 |