Analgesic Effects and Abuse Liability of Intravenous Hydromorphone and Buprenorphine in Pain-free Opioid Dependent Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Cold pressor test.
研究概览
简要总结
Pain is very common in persons with a history of addiction, but few studies have examined the best treatment of pain in this population. This is a study to determine the pain relief provided by intravenous hydromorphone (Dilaudid) or buprenorphine given to persons maintained on stable doses of methadone or buprenorphine. Experimental sessions will require overnight stays on a residential research unit. In these sessions, persons will be exposed to standard experimental pain techniques at baseline and then rate the relief (if any) provided by the study medication when exposed to the same techniques. Persons will be asked to participate in 2 or 3 sessions, each separated by at least 7 days.
详细描述
This research is being done to learn how to better treat pain in people maintained on opioid medications, like methadone and buprenorphine (Suboxone ®, Subutex ®). People who take opioid medications for long periods of time are known to experience pain differently; and, regular amounts of medications may not be enough to treat the pain of these individuals. Additionally, many people with a history of addiction are afraid of taking opioid pain relievers, like morphine or hydromorphone (Dilaudid ®), for fear of relapse.
This study will help guide the medical community on better pain treatment for people prescribed buprenorphine or methadone. Investigators also want to determine the risk for relapse in people who receive opioid pain relievers for the treatment of acute pain.
Healthy people aged 18-55 who are maintained on buprenorphine or methadone for the treatment of opioid dependence may take part in this study. Participants must be free of illicit drug use and be on a stable dose of methadone or buprenorphine. Initial screening will occur over the phone and then select participants will be scheduled for an in-person screening at the BPRU.
If a participant meets all criteria and agrees to participate, he or she will be enrolled into the study. Enrolled participants will have 2 or 3 sessions involving overnight stays on the Behavioral Pharmacology Research Unit (BPRU) residential unit.
- If participants are on methadone, they will have 2 sessions
- If participants are on buprenorphine, they will have 3 sessions.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of opioid dependence
- •urine toxicology negative for drugs of abuse but positive for opioid maintenance agent;
- •stable buprenorphine (12-16 mg) or methadone (80-100 mg) dose for the past 30 days;
- •absence of acute/chronic pain;
- •able and willing to perform/tolerate pain procedures;
- •able to communicate in English.
排除标准
- •current illicit substance use at screening or during trial (including cannabis use);
- •current diagnosis of alcohol dependence;
- •acute or chronic pain;
- •medical or psychiatric condition known to influence pain testing;
- •current use of prescribed or over the counter analgesic agents;
- •previous allergic reaction to hydromorphone or buprenorphine;
- •women who are pregnant, lactating or planning to get pregnant during the course of the trial.
研究组 & 干预措施
Methadone Maintenance
干预措施: Placebo (Drug)
Methadone Maintenance
干预措施: Hydromorphone (Drug)
Buprenorphine Maintenance
干预措施: Placebo (Drug)
Buprenorphine Maintenance
干预措施: Hydromorphone (Drug)
Buprenorphine Maintenance
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Cold pressor test.
时间窗: This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks.
The participant places a hand up to the wrist in a circulating water bath maintained at approximately 4 degrees Celsius (up to 5 minutes). The time at which pain develops is the threshold. The time a volunteer's hand remains underwater before pain is unbearable is tolerance.
次要结局
- Visual analog scales (VAS) of subjective drug effects.(This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks.)