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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA019989 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-week buprenorphine taper | Experimental | 1-week buprenorphine taper + behavioral therapy + urine toxicology |
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| 2-week buprenorphine taper | Experimental | 2-week buprenorphine taper + behavioral therapy + urine toxicology |
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| 4-week buprenorphine taper | Experimental | 4-week buprenorphine taper + behavioral therapy + urine toxicology |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| buprenorphine taper followed by naltrexone maintenance | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of subjects abstinent from all opioids through the final day of detoxification | up to 12-week trial |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of subjects retained in treatment through the final day of detoxification | up to 12-week trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacey C. Sigmon, Ph.D. | University of Vermont, Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Substance Abuse Treatment Center, University of Vermont | Burlington | Vermont | 05401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24153411 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 10, 2014 | |
| Reset | Sep 17, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 10, 2014 | Sep 17, 2014 |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Behavioral therapy | Behavioral |
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