Study of the Treatment of Experimental Pain in Buprenorphine Maintained Persons With Chronic Musculoskeletal Pain

NCT ID: NCT02372591

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-06-30

Brief 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 who have chronic musculoskeletal pain. 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 3 sessions, each separated by at least 7 days.

Conditions

Opioid-Related Disorders; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.

Hydromorphone

Group Type: ACTIVE_COMPARATOR

Hydromorphone

Intervention Type: DRUG

Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.

Buprenorphine

Group Type: EXPERIMENTAL

Buprenorphine

Intervention Type: DRUG

Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.

Interventions

Buprenorphine

Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.

Intervention Type: DRUG

Hydromorphone

Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.

Intervention Type: DRUG

Placebo

Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.

Intervention Type: DRUG

Other Intervention Names

Suboxone; Subutex; Dilaudid; Normal Saline

Eligibility Criteria

Inclusion Criteria

Opioid dependence according to the Mini International Neuropsychiatric Interview (MINI) and verified by the PI; urine toxicology negative for drugs of abuse but positive for opioid maintenance agent; stable buprenorphine (12-16 mg) dose for the past 30 days; chronic musculoskeletal pain (>3 months) as documented in medical history and physical; able and willing to perform/tolerate pain procedures; able to communicate in English.

Exclusion Criteria

Current illicit substance use at screening or during trial as verified by urine toxicology screen and/or self-report (including cannabis use); current alcohol dependence as assessed on the MINI); medical or psychiatric condition known to influence quantitative sensory testing (QST) (e.g. HIV, peripheral neuropathy, current Major Depressive Disorder, Schizophrenia, Raynaud's syndrome); use of prescribed or over the counter analgesic agents or psychotropic medications known to have analgesic properties for 24 hours prior to session; previous allergic reaction to hydromorphone or buprenorphine; women who are pregnant, lactating or planning to get pregnant during the course of the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

D. Andrew Tompkins, M.D. M.H.S.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

K23DA029609

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00093537

Identifier Type: -

Identifier Source: org_study_id