Alcohol use disorder (AUD) is a leading preventable cause of morbidity and mortality in the United States. Evidence-based treatments exist, but relapse rates among adults with AUD remain unacceptably high. Novel approaches that target known predictors of relapse are therefore urgently needed. Insomnia during abstinence is highly prevalent, persistent, and independently predicts relapse in adults with AUD. Pilot randomized controlled trials by our group and others have shown that CBT for insomnia (CBTi) improves sleep and daytime symptoms among patients with AUD and insomnia, but its impact on drinking has not been adequately tested. Moreover, despite the identified associations between insomnia and relapse, the sleep mechanisms underlying this relationship are poorly understood. Prior work has identified significant abnormalities in a candidate mechanism among adults with AUD, sleep homeostasis, which is a key sleep regulatory system reflecting ?sleep drive.? The objectives of this project, therefore, are to evaluate (a) the benefits of CBTi for sleep, drinking, and associated daytime symptoms and (b) the effects of CBTi on the homeostatic sleep system and its association with clinical outcomes in adults in AUD treatment with insomnia. One hundred and fifty adults entering AUD treatment at the University of Michigan Addiction Treatment Services with insomnia will be recruited and randomized to 6 weeks of either telemedicine-delivered CBTi (CBTi-TM, n=75) or Sleep Hygiene Education (SHE-TM, n=75). Drinking, sleep, and daytime symptom outcomes will be assessed pre- and post- treatment and at 3-, 6- and 12-month follow-up. Objective polysomnography will be conducted before and after treatment to assess homeostatic sleep drive.
The specific aims of the study are: (1) to determine whether CBTi-TM improves insomnia and daytime symptoms more than SHE-TM in adults in AUD treatment with insomnia; (2) to compare the efficacy of CBTi-TM to SHE-TM on alcohol relapse; and (3) to compare the effects of CBTi-TM to SHE-TM on homeostatic sleep drive. Secondary aims will assess the extent to which changes in alcohol use are mediated by changes in the CBTi-TM (vs. SHE-TM) effects on the homeostatic sleep system. The findings from this trial have important implications for the future treatment of patients with AUD to support continued abstinence.

Public Health Relevance

Relapse rates among adults with Alcohol Use Disorder (AUD) remain unacceptably high; thus, novel approaches are needed to improve treatment outcomes in this population. Insomnia is prevalent, persistent, and has been associated with relapse among adults with AUD, but sleep mechanisms underlying this relationship are poorly understood. This study will compare the effects of telemedicine-delivered Cognitive- Behavioral Therapy for Insomnia (CBTi-TM) to Sleep Hygiene Education (SHE-TM) on sleep, relapse, daytime outcomes and one candidate sleep mechanism - homeostatic sleep drive ? in adults receiving AUD treatment with insomnia.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Research Project (R01)
Project #
1R01AA028158-01
Application #
9916265
Study Section
Special Emphasis Panel (ZAA1)
Program Officer
Regunathan, Soundar
Project Start
2019-09-20
Project End
2024-08-31
Budget Start
2019-09-20
Budget End
2020-08-31
Support Year
1
Fiscal Year
2019
Total Cost
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Psychiatry
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109