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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00115037 |
This is a study involving treatment for alcohol dependence (alcoholism). The study will combine motivational enhancement therapy and cognitive behavioral therapy (combined behavioral intervention, or CBI) and test the benefits of continued/discontinued treatment with naltrexone in a randomized placebo-controlled trial. CBI may have advantages in motivating patients to greater medication adherence and may address psychosocial factors that may limit the effects of naltrexone.
Condition | Intervention | Phase |
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Alcoholism |
Drug: Naltrexone Drug: placebo Behavioral: Medical Management (MM) Behavioral: Combined Behavioral Intervention (CBI) Behavioral: Telephone Counseling Other: Treatment as Usual (TAU) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Non-Response to Naltrexone (NTX): Next Steps in Managing Alcoholism |
Enrollment: | 302 |
Study Start Date: | September 2003 |
Study Completion Date: | July 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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P1: Experimental
In phase 1, all participants on open-label naltrexone with MM.
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Drug: Naltrexone
100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
Behavioral: Medical Management (MM)
Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
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P2RA: Experimental
Phase 2: Naltrexone and TAU for phase 1 responders.
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Drug: Naltrexone
100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
Other: Treatment as Usual (TAU)
Responders are informed of the benefits of continued treatment with naltrexone and are given a four week supply of medication as well as a prescription for 3 months.
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P2RB: Experimental
Phase 2: Naltrexone and telephone counseling for phase 1 responders.
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Drug: Naltrexone
100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
Behavioral: Telephone Counseling
Biweekly telephone calls lasting 15-20 minutes focused on the same content as MM.
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P2NA: Experimental
Phase 2: naltrexone, MM and CBI for phase 1 non-responders.
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Drug: Naltrexone
100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
Behavioral: Medical Management (MM)
Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
Behavioral: Combined Behavioral Intervention (CBI)
45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.
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P2NB: Placebo Comparator
Phase 2: placebo, MM and CBI for phase 1 non-responders.
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Drug: placebo
placebo comparer for 16 weeks in phase 2.
Behavioral: Medical Management (MM)
Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
Behavioral: Combined Behavioral Intervention (CBI)
45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.
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Naltrexone has been established as an efficacious medication to treat alcohol dependence but studies thus far have focused mostly on the acute phase of treatment rather than long-term management and have not offered alternative treatment strategies when patients do not respond to an initial course of naltrexone. For these initial non-responders to naltrexone, it is unclear what adjustments to treatment should be made to increase the likelihood of treatment success. We are unaware of previous research focused specifically on naltrexone non-response. Pilot data from ongoing trials at our center, however, suggest that up to a third of patients fail to respond to naltrexone. Moreover, these non-responsive patients go on to have the worst outcomes during the next 6 months of treatment if maintained on the same combination of naltrexone and medication management (MM). We propose to augment medication management with a combination of motivational enhancement therapy and cognitive behavioral therapy (combined behavioral intervention - CBI) and to test the benefits of continued/discontinued treatment with naltrexone in a randomized placebo-controlled trial. Clinical strategies for second line treatments often favor switching treatments rather than augmentation. However, there may be synergies between naltrexone and CBI that were not apparent with medication management. Specifically, CBI may have advantages in motivating patients to greater medication adherence (a leading cause of naltrexone treatment failure) and CBI may address psychosocial factors that limited or attenuated the effects of naltrexone.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pennsylvania Treatment Research Center, Chestnut Street | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | David W. Oslin, M.D. | University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( David Oslin, M.D. ) |
Study ID Numbers: | NIAAAOSL014851 |
Study First Received: | June 20, 2005 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00115037 |
Health Authority: | United States: Federal Government |
Alcoholism alcohol abuse therapy drug resistance |
naltrexone patient care management human subject |
Mental Disorders Naltrexone Alcoholism Substance-Related Disorders |
Disorders of Environmental Origin Alcohol-Related Disorders Ethanol |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Narcotic Antagonists |
Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |