Effective Treatment for Prescription Opioid Abuse
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| ClinicalTrials.gov Identifier: NCT00719095 |
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Recruitment Status :
Completed
First Posted : July 21, 2008
Last Update Posted : April 15, 2013
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Sponsor:
University of Vermont Medical Center
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
University of Vermont Medical Center
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prescription Opioid Dependence | Drug: buprenorphine taper followed by naltrexone maintenance Behavioral: Behavioral therapy | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 105 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Effective Treatment for Prescription Opioid Abuse |
| Study Start Date : | April 2006 |
| Actual Primary Completion Date : | March 2010 |
| Actual Study Completion Date : | March 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Opioid addiction
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1-week buprenorphine taper
1-week buprenorphine taper + behavioral therapy + urine toxicology
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Drug: 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 Behavioral: Behavioral therapy |
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Experimental: 2-week buprenorphine taper
2-week buprenorphine taper + behavioral therapy + urine toxicology
|
Drug: 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 Behavioral: Behavioral therapy |
|
Experimental: 4-week buprenorphine taper
4-week buprenorphine taper + behavioral therapy + urine toxicology
|
Drug: 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 Behavioral: Behavioral therapy |
Primary Outcome Measures :
- percentage of subjects abstinent from all opioids through the final day of detoxification [ Time Frame: up to 12-week trial ]
Secondary Outcome Measures :
- percentage of subjects retained in treatment through the final day of detoxification [ Time Frame: up to 12-week trial ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719095
Locations
| United States, Vermont | |
| Substance Abuse Treatment Center, University of Vermont | |
| Burlington, Vermont, United States, 05401 | |
Sponsors and Collaborators
University of Vermont Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
| Principal Investigator: | Stacey C. Sigmon, Ph.D. | University of Vermont, Department of Psychiatry |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Stacey C. Sigmon, Ph.D., University of Vermont |
| ClinicalTrials.gov Identifier: | NCT00719095 |
| Other Study ID Numbers: |
R01DA019989 ( U.S. NIH Grant/Contract ) R01DA019989 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 21, 2008 Key Record Dates |
| Last Update Posted: | April 15, 2013 |
| Last Verified: | July 2008 |
Keywords provided by University of Vermont Medical Center:
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prescription opioid opioid detoxification buprenorphine |
naltrexone community reinforcement approach prescription opioid abuse |
Additional relevant MeSH terms:
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Opioid-Related Disorders Narcotic-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Naltrexone Buprenorphine Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists Alcohol Deterrents |