Effective Treatment for Prescription Opioid Abuse

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.

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.