Phase 3
N=20
Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial
Opioid-Related Disorders · Heroin Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00684554 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit. — 6; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Buprenorphine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit. |
6; 6 | — |
| SECONDARY Prolonged Withdrawal |
3; 3 | — |
Summary
The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic.
Eligibility Criteria
Inclusion Criteria
- DSM-IV criteria for current opioid dependence with physical dependence and are seeking treatment
- Recent opioid use
- Individuals must describe opioids as their primary drug of abuse.
- 18-65 years of age
- Able to give informed consent and comply with study procedures
- Financially able to receive treatment at AIM and obtain medication (e.g., Medicaid)
Exclusion Criteria
- DSM-IV opioid dependence without physical dependence
- Any current Axis I psychiatric disorder(s) as defined by DSM-IV-TR that in the investigator's judgment are unstable or would be disrupted by study participation (e.g., psychosis, active suicidal or homicidal ideation).
- Individuals who are significant risk for suicide based on their current mental state or history.
- DSM-IV alcohol or benzodiazepine dependence with physiologic dependence.
- Pregnancy, lactation. Women must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study.
- Unstable physical disorder that might make participation hazardous.
- Individuals with a known allergy, sensitivity or adverse reaction to buprenorphine.
- Past life-threatening idiosyncratic severe opioid withdrawal reaction (e.g., psychosis, seizure)
- Current buprenorphine maintenance
- Current long-acting opioid use (e.g., methadone)
- Inability to read or understand the self-report assessment forms unaided
Data sourced from ClinicalTrials.gov (NCT00684554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.