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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01642030
First Posted: July 17, 2012
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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.

Condition Intervention Phase
Opioid Dependence Pain Addiction Drug: Placebo Drug: Hydromorphone Drug: Buprenorphine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Effects and Abuse Liability of Intravenous Hydromorphone and Buprenorphine in Pain-free Opioid Dependent Participants

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Cold pressor test. [ Time Frame: 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.


Secondary Outcome Measures:
  • Visual analog scales (VAS) of subjective drug effects. [ Time Frame: This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks. ]
    VAS are single item questions that assessed subjective drug effects at the time of scale completion. Ratings are entered into a computer by the participant positioning an arrow along a 100 mm line marked at either end with "none" (0) and "extremely" (100).


Enrollment: 132
Actual Study Start Date: August 2013
Study Completion Date: July 2017
Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Methadone Maintenance Drug: Placebo
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.
Other Name: Normal Saline
Drug: Hydromorphone
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.
Other Name: Dilaudid
Buprenorphine Maintenance Drug: Placebo
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.
Other Name: Normal Saline
Drug: Hydromorphone
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.
Other Name: Dilaudid
Drug: Buprenorphine
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.
Other Names:
  • Suboxone
  • Subutex

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642030


Locations
United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: D. Andrew Tompkins, M.D., M.H.S. Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01642030     History of Changes
Other Study ID Numbers: NA_00071459
K23DA029609 ( U.S. NIH Grant/Contract )
1203 ( Other Identifier: PI )
First Submitted: July 9, 2012
First Posted: July 17, 2012
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by Johns Hopkins University:
Quantitative sensory testing
Cold pressor test
Opioid dependence
Methadone maintenance
Buprenorphine maintenance
Abuse liability
Diffuse Noxious Inhibitory Controls (DNIC)
Temporal Summation

Additional relevant MeSH terms:
Analgesics, Opioid
Buprenorphine
Methadone
Hydromorphone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents