Effective Treatment for Prescription Opioid Abuse

University of Vermont Medical Center

Status and phase: Completed; Phase 2

Conditions: Prescription Opioid Dependence

Treatments: Behavioral: Behavioral therapy; Drug: buprenorphine taper followed by naltrexone maintenance

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00719095

R01DA019989 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups

1-week buprenorphine taper

Experimental group

Description:

1-week buprenorphine taper + behavioral therapy + urine toxicology

Treatment:

Behavioral: Behavioral therapy

Drug: buprenorphine taper followed by naltrexone maintenance

2-week buprenorphine taper

Experimental group

Description:

2-week buprenorphine taper + behavioral therapy + urine toxicology

Treatment:

Behavioral: Behavioral therapy

Drug: buprenorphine taper followed by naltrexone maintenance

4-week buprenorphine taper

Experimental group

Description:

4-week buprenorphine taper + behavioral therapy + urine toxicology

Treatment:

Behavioral: Behavioral therapy

Drug: buprenorphine taper followed by naltrexone maintenance