Effective Treatment for Prescription Opioid Abuse
- Conditions
- Prescription Opioid Dependence
- Interventions
- Behavioral: Behavioral therapy
- Registration Number
- NCT00719095
- Lead Sponsor
- University of Vermont Medical Center
- Brief Summary
There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance.
- Detailed Description
There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance. Aim 1) Conduct a randomized, three-parallel-groups clinical trial (Study 1) to determine a buprenorphine dose-tapering schedule that prevents the poor retention and relapse that undermine many opioid detoxification regimens. Aim 2) Conduct a randomized, three-parallel-groups clinical trial (Study 2) to determine a duration of naltrexone therapy that sustains opioid abstinence following the buprenorphine detoxification.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- For inclusion in the proposed studies, subjects must be > 18 years old and in good health. Subjects must meet DSM-IV criteria for opioid dependence and FDA qualification criteria for buprenorphine treatment, including a history of opioid dependence and significant current opioid use (i.e., opioid-positive urines). Subjects must also be seeking or willing to accept opioid detoxification.
- Because the primary focus of the proposed research is to develop an efficacious intervention for prescription opioid abuse that employs a buprenorphine taper and subsequent naltrexone maintenance, individuals who require ongoing opioid therapy for pain or other chronic medical conditions will be excluded from participating.
- Individuals with evidence of an active psychiatric disorder that may interfere with consent or participation in the research (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., cardiovascular disease) or who are pregnant or nursing will be excluded from participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1-week buprenorphine taper buprenorphine taper followed by naltrexone maintenance 1-week buprenorphine taper + behavioral therapy + urine toxicology 1-week buprenorphine taper Behavioral therapy 1-week buprenorphine taper + behavioral therapy + urine toxicology 2-week buprenorphine taper buprenorphine taper followed by naltrexone maintenance 2-week buprenorphine taper + behavioral therapy + urine toxicology 2-week buprenorphine taper Behavioral therapy 2-week buprenorphine taper + behavioral therapy + urine toxicology 4-week buprenorphine taper buprenorphine taper followed by naltrexone maintenance 4-week buprenorphine taper + behavioral therapy + urine toxicology 4-week buprenorphine taper Behavioral therapy 4-week buprenorphine taper + behavioral therapy + urine toxicology
- Primary Outcome Measures
Name Time Method percentage of subjects abstinent from all opioids through the final day of detoxification up to 12-week trial
- Secondary Outcome Measures
Name Time Method percentage of subjects retained in treatment through the final day of detoxification up to 12-week trial
Trial Locations
- Locations (1)
Substance Abuse Treatment Center, University of Vermont
🇺🇸Burlington, Vermont, United States