Buprenorphine Naltrexone-P1 A-Cocaine
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ClinicalTrials.gov Identifier: NCT00733720 |
Recruitment Status
:
Completed
First Posted
: August 13, 2008
Last Update Posted
: January 12, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cocaine-related Disorders | Drug: Suboxone | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 8 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | January 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Each subject will receive all 3 doses of suboxone and placebo
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Drug: Suboxone
4/1mg, 8/2mg 16/4mg
Other Names:
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- Opioid Effects of study drug [ Time Frame: daily ]
- Adverse Events [ Time Frame: Daily ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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): NCT00733720
United States, California | |
Drug Dependence Research Center | |
San Fransisco, California, United States, 94143 |
Responsible Party: | Liza Gorgon, NIDA |
ClinicalTrials.gov Identifier: | NCT00733720 History of Changes |
Other Study ID Numbers: |
N01DA-6-8867 |
First Posted: | August 13, 2008 Key Record Dates |
Last Update Posted: | January 12, 2017 |
Last Verified: | October 2009 |
Additional relevant MeSH terms:
Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Buprenorphine Buprenorphine, Naloxone Drug Combination Naltrexone Naloxone |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |