Study of the Treatment of Experimental Pain in Opioid Dependent Persons on Methadone or Buprenorp… (NCT01642030) | Clinical Trial Compass
CompletedPhase 1
Study of the Treatment of Experimental Pain in Opioid Dependent Persons on Methadone or Buprenorphine Maintenance
United States132 participantsStarted 2013-08
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. age 18-55;
✓. 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.
Exclusion criteria
✕. 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;
What they're measuring
1
Cold pressor test.
Timeframe: This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks.