Opioid-Related Disorders
Conditions
Keywords
opioid dependence
Brief summary
The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form.
Detailed description
1\) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet = to liquid form
Interventions
DRUGBuprenorphine formulation: liquid vs. tablet
random assignment to liquid buprenorphine or tablet buprenorphine
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.
Exclusion criteria
Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood level | across study duration |
Secondary
| Measure | Time frame |
|---|---|
| drug use | across study duration |
| craving | across study duration |
| withdrawal symptoms | across study duration |
Countries
United States
Outcome results
None listed