Pioglitazone as an Aid During Buprenorphine Taper
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Treatment response, defined as opioid abstinence without severe withdrawal symptoms during the last week of the taper (week 6) and duration in treatment (retention)
研究概览
简要总结
Background:
- Opioid-withdrawal symptoms include runny nose, body aches, chills, sweating, and diarrhea. Many people have these symptoms when trying to stop using opioid drugs. Long-acting opioids like methadone and buprenorphine are used to help people stop using other opioids, but these drugs can cause the same withdrawal symptoms. There are no non-opioid drugs that are approved specifically to treat those symptoms.
- Pioglitazone is a drug used to treat type 2 diabetes. In a research study, the drug allowed heroin users to decrease their methadone dose faster without much discomfort, and stay abstinent from heroin. Researchers want to learn more about how pioglitazone helps treat opioid withdrawal symptoms.
Objectives:
- To test whether pioglitazone can reduce opioid withdrawal symptoms.
Eligibility:
- Individuals between 18 and 65 years of age who will be using buprenorphine to treat opioid dependency.
Design:
- This study will last up to 17 weeks. Participants must come to the study clinic every day for at least 13 weeks.
- Participants will be screened with a physical exam and medical history. They will also answer questions about drug use habits, and provide blood and urine samples.
- Participants will take buprenorphine daily for 7 weeks. For the first 3 weeks, the dose will be increased to a level that should help stop the use of opioids. For the next 4 weeks, the dose will be decreased. Blood, urine, and breath samples will be collected at different study visits. Participants will also fill out questionnaires about mood, drug craving, and withdrawal symptoms.
- After 1 week on buprenorphine, participants will start the study pill (pioglitazone or a placebo) every day. They will take the study pill for 13 weeks.
- During the treatment period, participants will have drug counseling once a week for 30 minutes.
- Some participants have other tests as part of this study. These tests include functional magnetic resonance imaging scans to look for changes in brain activity and giving samples of cerebrospinal fluid to study brain chemistry.
- Participants will have a final followup phone call 3 weeks after the last clinic visit.
详细描述
Background:
Some individuals successfully maintained on buprenorphine or methadone are appropriate candidates for dose tapering and transition to medication-free follow-up care. For such individuals, the physical discomfort of the dose taper can be a barrier to a successful transition. Recent data suggest a novel approach: the FDA-approved diabetes medication pioglitazone (Actos), which activates the gamma (g) subtype of peroxisome-proliferator-activated receptors (PPARs). Pioglitazone acts not only in peripheral tissue, but also in brain regions associated with drug tolerance and withdrawal. In animal models, pioglitazone prevents signs of opioid withdrawal. In a small, preliminary open-label clinical study, opioid-maintained outpatients given pioglitazone were remarkably successful in transitioning comfortably to a medication-free state, after prior unsuccessful attempts without pioglitazone. These initial data provide proof of principle and indicate that pioglitazone merits evaluation in a randomized-controlled study.
Scientific goals:
(1) To determine whether, compared to placebo, pioglitazone increases successful completion of an opioid agonist/antagonist taper in patients who are physically dependent on opioids. (2) To determine the neural mechanisms by which such an effect may occur.
Participant population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1
干预措施: Pioglitazone (Drug)
Group 2
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment response, defined as opioid abstinence without severe withdrawal symptoms during the last week of the taper (week 6) and duration in treatment (retention)
次要结局
- Overall proportions of opioid-negative urines, proportions of participants needing adjunct medications status at follow-up