NCT04581603

CBT-I Augmentation of Medication for Drinking in AUD

Cognitive Behavioral Therapy (CBT-I) Augmentation of Topiramate in Promoting Abstinence in Alcohol Use Disorder (AUD)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 by promoting abstinence and a reduction in drinking. Two of these medications (MED) used commonly are naltrexone and topiramate but they do not improve sleep continuity or insomnia. 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. However, these studies have involved subjects in early or sustained remission. The proposed study will evaluate whether augmenting MED with CBT-I, after reducing drinking or achieving abstinence, bolsters recovery in AUD, by decreasing insomnia and improving abstinence. If this strategy shows good clinical results and the findings are replicated in a multi-center trial then the combination of MED with CBT-I should be considered a standard component of the initial management of AUD with insomnia.

Detailed 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). Medications commonly used to treat pathological drinking and promote abstinence include Naltrexone and Topiramate. However, these medications do not improve 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 MED and CBT-I will improve their insomnia and bolster their recovery. 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=82) will be initially treated with a medication for drinking (MED), that will be either TOP 200 mg a day for six weeks, naltrexone 50 mg daily (and up to 100 mg daily), depot-naltrexone 380 mg injections every 4 weeks, or a combination of TOP + NTX. They will stabilized on the MED over 6 weeks and then randomized to receive either CBT-I (N=41) or Sleep Hygiene Education (SHE, a behavioral placebo intervention) (N=41) 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 end of the intervention phase. The primary outcome measure will be the the insomnia severity (as assessed using the Insomnia Severity Index). The secondary outcome measure will include the Percent Days Abstinent (as computed from the Time Line Follow Back interview). The investigators will also 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 MED+CBT-I, as compared to MED+SHE group, will lead to superior sleep-related outcomes along with pre-post treatment effect sizes comparable to the meta-analytic norms. On an exploratory basis, the MED + CBT-I arm will have a relatively higher percentage of days abstinent from alcohol and the improvement in insomnia and abstinence from drinking will show durability eight weeks after end of behavioral sleep treatment. 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 MED+CBT-I combination treatment to manage this subpopulation of AUD patients.

Conditions

• Alcohol Use Disorder With Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia	CBT-I is conducted weekly for eight sessions during which the subjects meet individual with the study clinician for 45 minutes on the first session and for 30 minutes for sessions 2-8. Session 1 serves as an orientation and the onset of Sleep Restriction Therapy. Sessions 2 \& 3 deliver the three main components that include, Sleep Restriction Therapy, Stimulus control, and Sleep Hygiene. All the sessions excluding the last two sessions are dedicated to the titration of total sleep time and to ensure patient adherence. The fifth session is used to deliver a specific form of cognitive therapy. The final session is used to engage the patient in a relapse-prevention didactic (i.e., to review how insomnia becomes chronic and strategies that abort an extended episode of insomnia). The subject will return on week 9 to complete the post-intervention visit after 8 weeks of behavioral sleep treatment.
BEHAVIORAL	Sleep Hygiene Education	This non-active control arm of behavioral sleep intervention consists of psychoeducation on sleep hygiene, sleep-related disturbances, and the effects of stress on sleep that will be delivered weekly for 8 weeks, for a time duration that is identical to the CBT-I sessions. The effect of stress on sleep is a commonly used control condition in insomnia clinical trials. SHE is preferred to a monitor-only condition as it will control for contact with the therapist and elapsed time during sessions. The subject will return on week 9 to complete the post-intervention visit after 8 weeks of behavioral sleep treatment.

Timeline

• Start date: 2022-06-15
• Primary completion: 2024-07-30
• Completion: 2025-01-20
• First posted: 2020-10-09
• Last updated: 2025-02-28

Locations

2 sites across 1 country: United States