Study of the Treatment of Experimental Pain in Opioid Dependent Persons on Methadone or Buprenorphine Maintenance

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Analgesics, Opioid; Buprenorphine; Hydromorphone; Methadone

Criteria

Inclusion Criteria:

1. age 18-55;

2. diagnosis of opioid dependence

3. urine toxicology negative for drugs of abuse but positive for opioid maintenance agent;

4. stable buprenorphine (12-16 mg) or methadone (80-100 mg) dose for the past 30 days;

5. absence of acute/chronic pain;

6. able and willing to perform/tolerate pain procedures;

7. able to communicate in English.

Exclusion Criteria:

1. current illicit substance use at screening or during trial (including cannabis use);

2. current diagnosis of alcohol dependence;

3. acute or chronic pain;

4. medical or psychiatric condition known to influence pain testing;

5. current use of prescribed or over the counter analgesic agents;

6. previous allergic reaction to hydromorphone or buprenorphine;

7. women who are pregnant, lactating or planning to get pregnant during the course of the trial.