Improving treatment outcomes for alcohol use disorder by targeting sleep issues
Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes
This study is testing whether helping people with alcohol use disorder who have trouble sleeping can improve their recovery by using two different sleep therapies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT04457674 on ClinicalTrials.gov |
What this trial studies
This study focuses on individuals with alcohol use disorder who also experience insomnia, aiming to improve their treatment outcomes. It evaluates two therapeutic approaches: Cognitive Behavioral Therapy for insomnia (CBTi) and Sleep Hygiene Education (SHE). Participants will be enrolled in an abstinence-based treatment program and will undergo assessments in a sleep laboratory. The study seeks to determine how effectively these interventions can manage insomnia and support recovery from alcohol use disorder.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with alcohol use disorder and chronic insomnia, who are in an abstinence-based treatment program.
Not a fit: Patients with sleep disorders other than insomnia or those with certain psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment outcomes for patients with alcohol use disorder by effectively managing their insomnia.
How similar studies have performed: Other studies have shown promising results in using cognitive behavioral therapy to address insomnia in patients with alcohol use disorder, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet probable Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Alcohol Use Disorder with ≤12 weeks of abstinence * Planned enrollment into an abstinence-based treatment program * Meet probable DSM-5 criteria for chronic insomnia, confirmed with sleep diary * Ability to travel to Ann Arbor for sleep laboratory assessments * Access to a video chat-capable device and reliable Wi-Fi network Exclusion Criteria: * Diagnosis of, or high suspicion for, sleep disorders other than insomnia * Meet probable DSM-5 criteria for bipolar disorder, psychotic disorder, or post-traumatic stress disorder (PTSD) * Terminal or progressive physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia), or presence of an unstable medical condition that is the specific cause of insomnia * Self-reported pregnancy or intention to become pregnant during the study
Where this trial is running
Ann Arbor, Michigan
- The University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: J Todd Arnedt, Ph.D. — University of Michigan
- Study coordinator: Libby Cardoni
- Email: mehobson@med.umich.edu
- Phone: 734.764.7175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.