Buprenorphine Naltrexone-P1 A-Cocaine
This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00733720
First received: August 11, 2008
Last updated: October 8, 2009
Last verified: October 2009
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Purpose
The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral naltrexone. This study will provide data to support the design of a similar study of the depot formulation of naltrexone and ultimately to study this combination for the treatment of cocaine dependence.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine-Related Disorders |
Drug: Suboxone |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers |
Resource links provided by NLM:
Drug Information available for:
Naloxone hydrochloride
Naloxone
Naltrexone
Naltrexone hydrochloride
Buprenorphine
Buprenorphine hydrochloride
U.S. FDA Resources
Further study details as provided by National Institute on Drug Abuse (NIDA):
Primary Outcome Measures:
- Opioid Effects of study drug [ Time Frame: daily ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Adverse Events [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 8 |
| Study Start Date: | August 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Each subject will receive all 3 doses of suboxone and placebo
|
Drug: Suboxone
4/1mg, 8/2mg 16/4mg
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Provide written informed consent
- Be male/female between the ages of 18-55
- Be in good physical and mental health as determined by interview and physical exam
- Have a body mass index between 18 and 30, inclusive
- Have no oral cavity pathology that would interfere with sublingual absorption of buprenorphine/naloxone or placebo
- Have negative qualitative urine toxicology screen for opioids, cocaine, benzodiazepines, and barbiturates prior to administration of the first dose of naltrexone
- Be able to comply with protocol requirements
- If female, have a negative pregnancy test and agree to use an acceptable method of birth control from date of consent and until two weeks after the last administration of study drug or placebo
Exclusion Criteria:
- please contact site for more information
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733720
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733720
Locations
| United States, California | |
| Drug Dependence Research Center | |
| San Fransisco, California, United States, 94143 | |
Sponsors and Collaborators
More Information
No publications provided
| Responsible Party: | Liza Gorgon, NIDA |
| ClinicalTrials.gov Identifier: | NCT00733720 History of Changes |
| Other Study ID Numbers: | N01DA-6-8867 |
| Study First Received: | August 11, 2008 |
| Last Updated: | October 8, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cocaine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Buprenorphine Naltrexone Analgesics Analgesics, Opioid Central Nervous System Agents |
Central Nervous System Depressants Narcotic Antagonists Narcotics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 26, 2015