Open-labeled Dose-extending Placebos as an Adjunct to Methadone Treatment: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Three-month dose of methadone
研究概览
简要总结
More than 2 million individuals in the United States have an Opioid Use Disorder (OUD). Methadone maintenance treatment is the gold standard of medication-assisted treatment for OUD, but high-dose methadone is associated with cardiotoxicity and respiratory complications, among other side effects. These adverse effects make enhancing the effectiveness of lower doses of methadone an attractive therapeutic goal. Long recognized for its capacity to enhance treatment outcomes for a wide range of neuropsychiatric disorders including pain, the placebo effect offers an as-yet untested avenue to such an enhancement. This approach is particularly compelling given that individuals with substance use disorder tend to have higher salience attribution, and may thereby be more sensitive to placebo effects. Our study combines two promising clinical methodologies-open-label placebo and conditioning-to investigate whether placebo effects can increase the effective potency of methadone in treatment-seeking OUD patients.
详细描述
A total of 120 newly-enrolled treatment-seeking OUD patients will be randomly assigned to one of two different groups: either methadone plus daily open-label placebo (OLP; treatment group), or methadone/Treatment as Usual (TAU; control). Participants will meet with study team members five times over the course of three months of treatment with methadone (baseline, 2 weeks, and 1, 2 and 3 months post-baseline). Throughout this study time period, methadone dosages will be adjusted by an addiction clinician blind to patient assignment, per standard clinical methods. The primary outcome is methadone dose at three months. Secondary outcomes include self-report of drug use; 3-month urine toxicology screen results; and treatment retention. Exploratory outcomes include several environmental as well as personality factors associated with OUD and with propensity to demonstrate a placebo effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age 18 or over)
- •Newly-admitted to the methadone treatment program
排除标准
- •Pregnancy
- •Transfers- patients who have initiated methadone treatment course at another methadone treatment facility
- •Hospital transfers- patients who initiated methadone treatment course in a hospital setting
- •Criminal justice referral
结局指标
主要结局
Three-month dose of methadone
时间窗: Three months (90 days)
Mean dose of methadone at 3 months (90 days) post-baseline (entry into treatment) will be evaluated for each of the two arms.
次要结局
- Treatment Retention(90 and 180 days post-baseline (entry into treatment))
- Subjective Opioid Withdrawal Scale (SOWS)(Baseline (entry into treatment), two-weeks post-baseline, and 1-, 2-, and 3-months post-baseline.)
- World Health Organization Quality of Life - Brief (WHOQOL-BREF) Assessment(Baseline (entry into treatment), and 1- and 3-months post-baseline)
- Craving assessment(Baseline (entry into treatment), two-weeks post-baseline, and 1-, 2-, and 3-months post-baseline.)
- Mean number of days of self-reported drug use(Baseline (entry into treatment), two-weeks post-baseline, and 1-, 2-, and 3-months post-baseline.)
- Objective Opioid Withdrawal Scale (OOWS)(Baseline (entry into treatment), two-weeks post-baseline, and 1-, 2-, and 3-months post-baseline.)
- Total number of days retained in treatment(One year post-baseline (entry into treatment))
- Urine Testing- Quick-tox Screen(Baseline)
- Pittsburgh Sleep Quality Inventory (PSQI)(Baseline (entry into treatment), and 1- and 3-months post-baseline)
研究者
Annabelle Belcher
Assistant Professor of Psychiatry
University of Maryland, Baltimore