Heroin Dependence, Opioid-Related Disorders
Conditions
Keywords
Heroin Dependence
Brief summary
The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.
Detailed description
Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.
Interventions
DRUGHeroin Dependence
Sponsors
National Institute on Drug Abuse (NIDA)
University of Colorado, Denver
Study design
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
Individuals must be currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.
Exclusion criteria
Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug use | — |
| Retention | — |
| Subjective dose estimate | — |
| Observed withdrawal rating | — |
| Opioid agonist rating | — |
| Opioid antagonist rating | — |
| Pupil diameter | — |
| Compliance | — |
| Analog rating scale for drug effects | — |
| Drug effect characteristics | — |
| Dose order estimate-nurse | — |
| Dose order estimate-client | — |
Countries
United States
Outcome results
None listed