The Effects of Intranasal Oxytocin on Mixed HIV Sero-status, Methamphetamine-using Men Who Have Sex With Men
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Side effect profile
研究概览
简要总结
The purpose of this pilot study is to determine the tolerability, feasibility, and preliminary effectiveness of intranasal oxytocin administration prior to motivational enhancement group therapy sessions on laboratory-based measures of addiction, social connectedness, and stress responsivity in methamphetamine(meth)-using men who have sex with men (MSM). The investigators propose a randomized, double-blind, study of intranasal oxytocin versus placebo 40 IU prior to each of six Motivational Interviewing Group Therapy (MIGT) sessions in 28 mixed HIV sero-status MSM initiating treatment for amphetamine use disorder.
详细描述
The high prevalence of amphetamine use disorder (AUD) among men who have sex with men (MSM) leads to significant health disparities, including increased risk for HIV sero-conversion. Reducing methamphetamine use mitigates HIV risk. Currently no psychopharmacological agent exists for the treatment of AUD; innovative interventions are desperately needed. Oxytocin, a social neuropeptide, has well-studied anti-addiction effects in animal models of substance dependence. The use of intranasal oxytocin for a variety of human substance use disorders is under early investigation, although no one has studied oxytocin's effects in AUD. In other populations, oxytocin's effects are known to vary depending on social context. Psychosocial treatment alone has been shown to reduce methamphetamine and HIV risk in MSM at a community-based clinic in San Francisco, The Stonewall Project. The investigators propose a randomized, double-blind pilot study of psychopharmacological-psychosocial combination therapy, administration of intranasal oxytocin versus placebo prior to six Motivational Interviewing Group Therapy (MIGT) sessions, in 28 mixed HIV sero-status MSM initiating treatment for AUD. The investigators aim to assess: 1) tolerability, 2) feasibility for larger randomized controlled trials, and 3) exploratory measures of efficacy, including: a) urine levels of methamphetamine and metabolites, b) methamphetamine craving, c) engagement in MIGT through third-party coding of videotaped group sessions and self-reported measures of group connectedness, d) psychophysiological stress responses to group engagement, and e) sexual risk taking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •One documented urine toxicology screen positive for meth in the past month
- •Considering initiating treatment for Methamphetamine Use Disorder or initiated treatment within the past month
- •History of sexual contact with men.
排除标准
- •Urine toxicology screen positive for heroin in the past month
- •Meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for current psychotic disorder, severe neuropsychological disorder, current moderate-severe alcohol use disorder, or suicidal or homicidal ideation with intent within the past 90-days
- •Hemodialysis or inability to produce urine samples
- •Sensitivity to: E 216, E 218, and chlorobutanol hemihydrate (preservatives used in nasal spray)
- •Nasal Obstruction or discharge
- •Using Hormone supplementation
研究组 & 干预措施
Oxytocin
Oxytocin 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions.
干预措施: Oxytocin (Drug)
Placebo
Placebo 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions.
干预措施: Placebo (Drug)
结局指标
主要结局
Side effect profile
时间窗: 6 weeks
Aim 1: To examine the tolerability of repeated oxytocin dosing in MSM who use meth. Hypothesis 1: There will be no difference in side effect profiles for those receiving oxytocin (40 IU) versus placebo prior to each of six MIGT sessions, and there will be no study-related adverse events.
次要结局
- urine toxicology(6 weeks)
- Recruitment Rates(6 weeks)
- Meth Craving Questionnaire-Brief (MCQ-Br)(6 weeks)
- heart rate variability(6 weeks)
- attendance rate(6 weeks)
- Group Questionnaire(6 weeks)
研究者
Christopher Stauffer
Principal Investigator
University of California, San Francisco
