Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence
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Purpose
Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone when given through different routes and at different doses.
| Condition | Intervention |
|---|---|
|
Opioid-Related Disorders |
Drug: Buprenorphine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals |
- Opioid agonist rating [ Time Frame: up to one day ] [ Designated as safety issue: Yes ]
- opiate withdrawal [ Time Frame: up to one day ] [ Designated as safety issue: Yes ]
- physiologic measures [ Time Frame: up to one day ] [ Designated as safety issue: Yes ]
| Enrollment: | 10 |
| Study Start Date: | August 1996 |
| Study Completion Date: | May 1998 |
| Primary Completion Date: | April 1998 (Final data collection date for primary outcome measure) |
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Drug: Buprenorphine
Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to characterize the effects of buprenorphine/naloxone in opioid-dependent individuals.
This study will last 10 weeks. Participants will stay in a residential research unit, and will be maintained on oral hydromorphone (10 mg). During twice-weekly experimental sessions, participants will be randomly assigned to receive either sublingual tablets, intramuscular injections, or a placebo. The 15 conditions studied will include: sublingual or intramuscular buprenorphine/naloxone (1/0.25 mg, 2/0.5 mg, 4/1 mg, 8/2 mg, and 16/4 mg), 0.25 mg of intramuscular naloxone (antagonist control), 10 mg of intramuscular hydromorphone (agonist control), sublingual and intramuscular buprenorphine (8 mg), and placebo.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Currently opioid dependent
- In good health, as determined by a pre-participation medical examination
- Seeking and eligible for methadone maintenance or detoxification treatment
Exclusion Criteria:
- Significant medical or psychiatric illness, other than drug dependence
Contacts and Locations| United States, Maryland | |
| Johns Hopkins University (BPRU) Bayview Campus | |
| Baltimore, Maryland, United States, 21224 6823 | |
| Principal Investigator: | Eric C. Strain, MD | Johns Hopkins University |
More Information
Publications:
| Responsible Party: | Eric C. Strain/Principal Investigator, Johns Hopkins University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00134914 History of Changes |
| Other Study ID Numbers: | NIDA-08045-4, R01-08045-4, DPMC |
| Study First Received: | August 23, 2005 |
| Last Updated: | July 11, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Buprenorphine Analgesics, Opioid Naloxone Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 22, 2013