Oregon Health and Science University, Department of Medicine, Division of General Internal Medicine and Geriatrics, Addiction Medicine Section, Portland, OR, USA.
Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Addiction. 2023 Jul;118(7):1320-1328. doi: 10.1111/add.16163. Epub 2023 Mar 2.
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.
This was a secondary analysis of ADAPT-2, a randomized, double-blind, placebo-controlled, multicenter, two-stage sequential parallel comparison design trial.
United States.
This study comprised 126 women (403 total participants); average age = 40.1 years (standard deviation = 9.6) with moderate to severe MUD.
Interventions were combination intramuscular naltrexone (380 mg/3 weeks) and oral bupropion (450 mg daily) versus placebo.
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.
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).
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.
社会文化（性别）和生物（性）差异导致了对精神兴奋剂的易感性，这可能会影响到患有甲基苯丙胺使用障碍（MUD）的女性对治疗的反应。本研究的目的是测量：（i）与男性相比，患有 MUD 的女性独立接受治疗和安慰剂治疗的反应如何；（ii）在女性中，激素避孕方法（HMC）如何影响治疗反应。
这是 ADAPT-2 的二次分析，ADAPT-2 是一项随机、双盲、安慰剂对照、多中心、两阶段序贯平行比较设计试验。
美国。
本研究包括 126 名女性（共 403 名参与者）；平均年龄为 40.1 岁（标准差=9.6），患有中度至重度 MUD。
干预措施为肌肉注射纳曲酮（380mg/3 周）和口服安非他酮（450mg 每日）联合治疗与安慰剂治疗。
治疗反应通过在每个阶段的最后 2 周内至少有四次阴性甲基苯丙胺尿液药物测试来衡量；治疗效果是每个阶段加权治疗反应的差异。
在基线时，女性使用甲基苯丙胺的天数比男性少[15.4%比 23.1%，P=0.050，差异=-7.7，95%置信区间（CI）=-15.0 至 -0.3]，且更多的女性比男性患有焦虑症[59.5%比 47.6%，P=0.027，差异=11.9%，95%CI=1.5 至 22.3%]。在 113 名（89.7%）有生育能力的女性中，有 31 名（27.4%）使用了 HMC。在治疗的第 1 阶段和第 2 阶段，分别有 29%和 5.6%的女性有反应，而安慰剂组分别有 3.2%和 0%有反应。研究结果发现女性和男性的治疗效果均独立存在（P<0.001）；且男女之间没有治疗效果的差异（女性 0.144，男性 0.100；P=0.363，差异=0.044，95%CI=-0.050 至 0.137）。HMC 的使用对治疗效果没有影响（HMC 组 0.156，无 HMC 组 0.128；P=0.769，差异=0.028，95%CI=-0.157 至 0.212）。
接受肌肉注射纳曲酮和口服安非他酮联合治疗的患有甲基苯丙胺使用障碍的女性，其治疗反应优于安慰剂。HMC 的使用对治疗效果没有影响。
