Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence
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ClinicalTrials.gov Identifier: NCT00555425 |
Recruitment Status
:
Completed
First Posted
: November 8, 2007
Results First Posted
: January 24, 2017
Last Update Posted
: March 7, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Opiate Dependence | Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn) Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 113 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.
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Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn)
Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
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Experimental: 2
Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.
|
Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx)
Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.
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- Illicit Opioid Use [ Time Frame: 18 weeks ]Urinalysis based on scheduled weekly urine screenings during treatment period
- Proportion of Patients Protectively Transferred [ Time Frame: 18 weeks ]>= 2 consecutive weeks of daily illicit opioid use and opioid positive urine samples after completion of the first 6 weeks of the study
- Retention in Treatment [ Time Frame: 18 weeks ]Mean number of days from randomization to last clinical contact
- Reduction in Cocaine Use [ Time Frame: 18 weeks ]As measured by the percent of provided urines positive for cocaine
- Changes in HIV Risk [ Time Frame: Baseline and 18 weeks ]
As measured by the AIDS Risk Inventory. The AIDS Risk Inventory (ARI) is a 166 item structured interview that assesses the number and frequency of drug-related and sexual risk behaviors in the preceding 3 months. Calculation of the ARI total score is based on the frequency of occurrence of a given behavior and on the recency of this behavior, with recency being weighted more than a life-time occurrence of the same behavior. Higher values are associated with greater risk of HIV transmission (worse).
There are 10 subscales comprised of between 8 and 24 items. Subscales scores are based on the sum of the individual items and the overall ARI total score is the sum of the subscales.
Scores can range from 0 to 350, although among opioid dependent patients most values are below 100 with means between 50 and 60 depending on characteristics of the patients and treatment status.
- Patient Satisfaction [ Time Frame: 18 weeks ]Patient satisfaction as measured by survey. Primary Care Buprenorphine Satisfaction Scale (PCBSS). Comprises of 19 items evaluating satisfaction with staff expertise, concern, and responsiveness. Range of scores from 15-95. I higher score indicates greater satisfaction.
- Health Status [ Time Frame: 18 weeks ]Measured by the SF-36 overall transformed measure. In the SF-36 all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- opioid dependence
Exclusion Criteria:
- current dependence on alcohol, cocaine, benzodiazepines or sedatives
- current suicide or homicide risk
- current psychotic disorder or untreated major depression
- inability to read or understand English
- life-threatening or unstable medical problems

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): NCT00555425
United States, Connecticut | |
The APT Foundation, Inc. -- Welch Building | |
New Haven, Connecticut, United States, 06519 | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06520 |
Principal Investigator: | David A. Fiellin, MD | Yale University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | David Fiellin, Professor of Medicine, Yale University |
ClinicalTrials.gov Identifier: | NCT00555425 History of Changes |
Obsolete Identifiers: | NCT00595400 |
Other Study ID Numbers: |
1R01DA020576-01A1 ( U.S. NIH Grant/Contract ) R01DA020576 ( U.S. NIH Grant/Contract ) DPMC ( Other Identifier: NIDA ) |
First Posted: | November 8, 2007 Key Record Dates |
Results First Posted: | January 24, 2017 |
Last Update Posted: | March 7, 2017 |
Last Verified: | January 2017 |
Keywords provided by David Fiellin, Yale University:
Buprenorphine Buprenorphine/naloxone Counseling Primary care |
Additional relevant MeSH terms:
Opioid-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Buprenorphine Buprenorphine, Naloxone Drug Combination Naloxone Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |