Study Summary
This trial will help researchers understand if treating insomnia can also help treat alcohol use disorder.
Eligible Conditions
- Insomnia
- Alcohol Abuse
Treatment Effectiveness
Effectiveness Progress
Study Objectives
8 Primary · 10 Secondary · Reporting Duration: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Week 7
Recruitment
Retention
Month 3
Alcohol craving
Alcohol-related consequences
Autonomic arousal
Client satisfaction
Delay discounting
Drinking quantity
Emotion regulation
Insomnia symptoms
Negative affect
Response inhibition
Self-reported executive function
Sleep efficiency
Sleep quality
Use of alcohol to help with sleep
Use of sleep medication
Working memory updating
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Sleep Hygiene
1 of 2
CBT-I
1 of 2
Active Control
Experimental Treatment
68 Total Participants · 2 Treatment Groups
Primary Treatment: Sleep Hygeine · No Placebo Group · N/A
CBT-IExperimental Group · 2 Interventions: Cognitive Behavioral Therapy for Insomnia, Sleep Hygeine · Intervention Types: Behavioral, Behavioral
Sleep Hygiene
Behavioral
ActiveComparator Group · 1 Intervention: Sleep Hygeine · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia
2013
Completed Phase 3
~1300
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22)
Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
719 Previous Clinical Trials
1,174,073 Total Patients Enrolled
3 Trials studying Insomnia
369 Patients Enrolled for Insomnia
University of Missouri-ColumbiaLead Sponsor
329 Previous Clinical Trials
600,622 Total Patients Enrolled
8 Trials studying Insomnia
709 Patients Enrolled for Insomnia
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:A veteran who was deployed for military service after September 11, 2001, is now able to request expedited processing of their disability application.
Heavy drinking episodes, defined as drinking four or five drinks in two hours for women and men, respectively, occurred on at least one day in the past 30 days for 1 in 5 U.S
The DSM-5 includes a diagnosis of insomnia disorder, which is characterized by difficulty falling asleep, difficulty staying asleep, or early morning awakening with difficulty returning to sleep
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Conditions
Cancer Related
Treatments