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

NCT01642030 | Completed Phase 1

• 3 other identifiers: NA_00071459K23DA0296091203
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Opioid Dependence; Pain; Addiction

Keywords

Quantitative sensory testing; Cold pressor test; Opioid dependence; Methadone maintenance; Buprenorphine maintenance; Abuse liability; Diffuse Noxious Inhibitory Controls (DNIC); Temporal Summation

Outcome Measures

Primary Outcomes (1)

• Cold pressor test.

  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.

  This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks.

Secondary Outcomes (1)

• 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.

Study Arms (2)

Methadone Maintenance

OTHER

Drug: Placebo; Drug: Hydromorphone

Buprenorphine Maintenance

OTHER

Drug: Placebo; Drug: Hydromorphone; Drug: Buprenorphine

Interventions

Placebo DRUG

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

Also known as: Normal Saline

Buprenorphine Maintenance; Methadone Maintenance

Hydromorphone DRUG

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

Also known as: Dilaudid

Buprenorphine Maintenance; Methadone Maintenance

Buprenorphine DRUG

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

Also known as: Suboxone, Subutex

Buprenorphine Maintenance

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Pain; Behavior, Addictive

Interventions

Saline Solution; Hydromorphone; Buprenorphine; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone; Drug Combinations

Study Officials

• D. Andrew Tompkins, M.D., M.H.S.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 17, 2012
• Study Start: August 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

US (1)