CBT-I Augmentation of TOP for Sobriety and Insomnia in AUD

  • STATUS
    Recruiting
  • End date
    Oct 12, 2026
  • participants needed
    174
  • sponsor
    VA Office of Research and Development
Updated on 19 August 2021

Summary

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. Among them, topiramate (TOP) has demonstrated promise in improving abstinence and decreasing heavy drinking but without any clinical improvement in sleep continuity. 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. The proposed study will evaluate whether augmenting TOP with CBT-I bolsters recovery in AUD, by improving abstinence and decreasing insomnia. If this strategy shows good clinical results and the findings are replicated in a multi-center trial then the combination of TOP with CBT-I should be considered a standard component of the initial management of AUD with insomnia.

Description

Alcohol Use Disorder (AUD) and insomnia are both more prevalent among Veterans than in the general population. While insomnia is 3-9 times more prevalent in AUD than in the general population, patients with comorbid AUD and insomnia suffer from higher severity of AUD with increased alcohol craving, reduced quality of life, impaired interpersonal functioning, higher risks for suicidal behavior and relapse during early abstinence. There are limited options to treat drinking behavior and insomnia due to side effect profile (disulfiram) or only modest impact on drinking outcomes (naltrexone and acamprosate). Topiramate (TOP), an FDA-approved medication for seizures and migraines, showed moderate effect sizes in achieving abstinence and decreasing craving, when compared to placebo, in a recent meta-analysis. However, TOP therapy did not provide clinical improvement in objective sleep or subjective insomnia. Furthermore, hypnotic medication treatments with trazodone, gabapentin, and ramelteon have shown variable impact for sleep disturbance and abstinence. By contrast, all four studies evaluating Cognitive Behavioral Therapy for Insomnia (CBT-I) have shown a large magnitude of effect for treating insomnia but with minimal to no effect on abstinence. Thus, combining TOP and CBT-I will strengthen their recovery and improve their overall functioning. This combination treatment will be the first personalized intervention in treating Veterans with AUD and comorbid insomnia.

A sample of treatment-seeking Veterans with AUD (N=174) will be initially treated with TOP 200 mg a day for six weeks, and then randomized to receive either CBT-I (N=87) or Sleep Hygiene Education (SHE, a behavioral placebo intervention) (N=87) weekly for the next eight weeks. The investigators will conduct CBT-I following the standard protocol using 30-minute sessions to deliver its components (Sleep Restriction, Stimulus Control, Sleep Hygiene and Cognitive Therapy). A post-intervention visit will be conducted eight weeks after the intervention phase. The primary outcome measure will be the Percent Days Abstinent (as computed from the Time Line Follow Back interview) and the insomnia severity (as assessed using the Insomnia Severity Index). Also, the investigators will track other aspects of alcohol use, sleep and daily functioning using TLFB, PACS, sleep diaries, BDI, and the STAI to test whether successful treatment of drinking and insomnia will be associated with better clinical outcomes in AUD. It is hypothesized that in Veterans with AUD, the combination of TOP+CBT-I, as compared to TOP+SHE group, will lead to 1) a more significant percentage of days abstinent from alcohol, and 2) superior sleep-related outcomes along with pre-post treatment effect sizes comparable to the meta-analytic norms. If these hypotheses are supported, the findings will need to be validated in a larger multi-center trial. If validated, the findings would support: 1) including insomnia treatment as a standard component of the initial protocol for treating AUD comorbid with insomnia, and 2) using TOP+CBT-I combination treatment to manage this subpopulation of AUD patients.

Details
Condition Alcohol Use Disorder With Insomnia
Treatment Cognitive Behavioral Therapy for Insomnia, Sleep hygiene education, Topiramate (TOP)
Clinical Study IdentifierNCT04581603
SponsorVA Office of Research and Development
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

actively drinking alcohol in the past month
a current diagnosis of moderate or severe AUD (i.e., meeting 4 of the 11 DSM-5 criteria for AUD)
insomnia of moderate or higher severity (i.e., ISI total score 15)
expressed desire to reduce or stop drinking
able to read English at the 8th grade reading level
able to comprehend and give informed consent (Blessed Orientation-Memory-Concentration test weighted score <16)
women of child-bearing potential (i.e., who has not had a hysterectomy, bilateral oophorectomy, tubal ligation or is less than two years postmenopausal)
must be non-lactating
practicing a reliable method of birth control
have a negative serum pregnancy test prior to start of treatment

Exclusion Criteria

a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including direct bilirubin elevations of >110% or a transaminase elevation >300% of normal
history of nephrolithiasis
history of glaucoma
history of hypersensitivity to TOP
current serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, eating disorder, or imminent suicide or violence risk)
DSM-5 criteria for any other substance used disorder, but excluding nicotine, cannabis and mild cocaine use disorder
untreated patients with the diagnosis of moderate-severe obstructive sleep apnea with Total Apnea-Hypopnea Index (AHI-T) of 15 events/hour of sleep
current treatment with medications considered a high risk for adverse reactions, such as opioid analgesics and carbonic anhydrase inhibitors
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