Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)

Insomnia Clinical Trial

Official title:

Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04457674
• Other study ID #: HUM00173631
• Secondary ID: R01AA028158
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: Mandilyn Graham
• Phone: 734-232-0276
• Email: grmandil[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Insomnia is common in people who are in treatment for alcohol use disorder. It can impact both sleep quality and daytime functioning, as well as make it harder to treat the underlying alcohol use disorder. This study is looking at two types of therapy to help manage insomnia specifically for people also in treatment for alcohol use disorder.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Insomnia

Intervention

Behavioral:
• Cognitive Behavioral Therapy for insomnia (CBTi)
CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
• Sleep Hygiene Education (SHE)
SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score from the insomnia severity index (ISI)	The ISI is a 7-item self-report assessment of the nature, severity and impact of insomnia. Scores range from 0-28 with higher scores suggesting more clinically significant insomnia.	Immediately post treatment
Primary	Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB)	The Alcohol TLFB is an interviewer-based drinking assessment method to estimate drinking behaviors, including both frequency and quantity of consumption.	Immediately post treatment
Secondary	Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale	The MFI is a 20-item assessment that provides an overall fatigue score (20-100) in addition to 5 separate dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Sub-scale scores range from 4-20 with higher scores indicating higher levels of fatigue.	Immediately post treatment