At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓DSM-IV diagnosis of alcohol dependence confirmed by MINI interview
- ✓Drank alcohol within 30 days of randomization
- ✓Minimum 48 standard drinks (avg. 12/week) in a consecutive 30-day period during the 90 days prior to intake
- ✕Opiate abuse or dependence in past 12 months, or evidence of opiate use in month prior to treatment (prescription opioids allowed only if discontinued by randomization)
- ✕Current or recent dependence, abuse, or partial remission on substances other than alcohol (except nicotine and marijuana); positive urine drug screen (except THC) at initial visit or repeat testing
- ✕Lifetime DSM-IV diagnosis of schizophrenia or any psychotic disorder
- ✕Current DSM-IV diagnosis of post-traumatic stress disorder (PTSD) or bipolar disorder, or other disorders interfering with study participation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Non-Response to Naltrexone (NTX): Next Steps in Managing Alcoholism
In Brief
A Phase 4 clinical trial evaluating Naltrexone, placebo, and 3 other interventions for Alcoholism. Completed, enrolled 302 participants across 1 site.
Detailed Summary
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 tests 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.
Study Details
Timeline
Interventions
100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.
placebo comparer for 16 weeks in phase 2.
Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.
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.
Bi-weekly telephone calls lasting 15-20 minutes focused on the same content as MM.