Effective Treatment for Prescription Opioid Abuse

NCT ID: NCT00719095

Last Updated: 2013-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2010-03-31

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.

Conditions

Prescription Opioid Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1-week buprenorphine taper

1-week buprenorphine taper + behavioral therapy + urine toxicology

Group Type: EXPERIMENTAL

buprenorphine taper followed by naltrexone maintenance

Intervention Type: DRUG

direct comparison of 1-, 2- and 4-week durations of buprenorphine taper for treating prescription opioid abusers; those who successfully taper without resumption of illicit opioid use are subsequently transitioned to oral naltrexone therapy for the remainder of the 12-week trial; all participants receive a platform of intensive individual behavioral therapy and on-site urinalysis monitoring throughout the trial

Behavioral therapy

Intervention Type: BEHAVIORAL

2-week buprenorphine taper

2-week buprenorphine taper + behavioral therapy + urine toxicology

Group Type: EXPERIMENTAL

buprenorphine taper followed by naltrexone maintenance

Intervention Type: DRUG

direct comparison of 1-, 2- and 4-week durations of buprenorphine taper for treating prescription opioid abusers; those who successfully taper without resumption of illicit opioid use are subsequently transitioned to oral naltrexone therapy for the remainder of the 12-week trial; all participants receive a platform of intensive individual behavioral therapy and on-site urinalysis monitoring throughout the trial

Behavioral therapy

Intervention Type: BEHAVIORAL

4-week buprenorphine taper

4-week buprenorphine taper + behavioral therapy + urine toxicology

Group Type: EXPERIMENTAL

buprenorphine taper followed by naltrexone maintenance

Intervention Type: DRUG

direct comparison of 1-, 2- and 4-week durations of buprenorphine taper for treating prescription opioid abusers; those who successfully taper without resumption of illicit opioid use are subsequently transitioned to oral naltrexone therapy for the remainder of the 12-week trial; all participants receive a platform of intensive individual behavioral therapy and on-site urinalysis monitoring throughout the trial

Behavioral therapy

Intervention Type: BEHAVIORAL

Interventions

buprenorphine taper followed by naltrexone maintenance

direct comparison of 1-, 2- and 4-week durations of buprenorphine taper for treating prescription opioid abusers; those who successfully taper without resumption of illicit opioid use are subsequently transitioned to oral naltrexone therapy for the remainder of the 12-week trial; all participants receive a platform of intensive individual behavioral therapy and on-site urinalysis monitoring throughout the trial

Intervention Type: DRUG

Behavioral therapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Vermont Medical Center

OTHER

Sponsor Role: lead

Responsible Party

University of Vermont

Principal Investigators

Stacey C. Sigmon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Vermont, Department of Psychiatry

Locations

Substance Abuse Treatment Center, University of Vermont

Burlington, Vermont, United States

Countries

United States

References

Sigmon SC, Dunn KE, Saulsgiver K, Patrick ME, Badger GJ, Heil SH, Brooklyn JR, Higgins ST. A randomized, double-blind evaluation of buprenorphine taper duration in primary prescription opioid abusers. JAMA Psychiatry. 2013 Dec;70(12):1347-54. doi: 10.1001/jamapsychiatry.2013.2216.

Reference Type: DERIVED

PMID: 24153411 (View on PubMed)

Other Identifiers

R01DA019989

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA019989

Identifier Type: NIH

Identifier Source: org_study_id

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