Buprenorphine Naltrexone-P1 A-Cocaine

National Institutes of Health (NIH)

Status and phase: Completed; Phase 1

Conditions: Cocaine-related Disorders

Treatments: Drug: Suboxone

Study type: Interventional

Funder types: NIH

Identifiers

NCT00733720

N01DA-6-8867

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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8 participants in 1 patient group

1

Active Comparator group

Description:

Each subject will receive all 3 doses of suboxone and placebo

Treatment:

Drug: Suboxone