Cocaine-related Disorders
Conditions
Brief summary
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.
Interventions
DRUGSuboxone
4/1mg, 8/2mg 16/4mg
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Opioid Effects of study drug | daily |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events | Daily |
Countries
United States
Outcome results
None listed