CBT-I Augmentation of Medication for Drinking in AUD
Public ClinicalTrials.gov record NCT04581603. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Cognitive Behavioral Therapy (CBT-I) Augmentation of Topiramate in Promoting Abstinence in Alcohol Use Disorder (AUD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Alcohol Use Disorder (AUD) and insomnia are more prevalent in Veterans than in the general community. Furthermore, insomnia is comorbid in 36-91% of individuals with AUD and jeopardizes recovery by increasing their risk for relapse and complicating their clinical profile. The VA/DoD guidelines recommend four medications for the treatment of AUD by promoting abstinence and a reduction in drinking. Two of these medications (MED) used commonly are naltrexone and topiramate but they do not improve sleep continuity or insomnia. The recommended treatment for insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I), and it has shown efficacy in improving insomnia but with minimal benefit in improving abstinence. However, these studies have involved subjects in early or sustained remission. The proposed study will evaluate whether augmenting MED with CBT-I, after reducing drinking or achieving abstinence, bolsters recovery in AUD, by decreasing insomnia and improving abstinence. If this strategy shows good clinical results and the findings are replicated in a multi-center trial then the combination of MED with CBT-I should be considered a standard component of the initial management of AUD with insomnia.
Study identification
- NCT ID
- NCT04581603
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 82 participants
Conditions and interventions
Conditions
Interventions
- Cognitive Behavioral Therapy for Insomnia Behavioral
- Sleep Hygiene Education Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 14, 2022
- Primary completion
- Jul 29, 2024
- Completion
- Jan 19, 2025
- Last update posted
- Feb 27, 2025
2022 – 2025
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Coatesville VA Medical Center, Coatesville, PA | Coatesville | Pennsylvania | 19320 | — |
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104-4551 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04581603, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 27, 2025 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04581603 live on ClinicalTrials.gov.