CBT-I Augmentation of Medication for Drinking in AUD

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Alcohol Use Disorder With Insomnia

In brief

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.

Key facts

Study ID

NCT04581603

Run by

VA Office of Research and Development

People needed

82

Starts

2022-06-15

Expected to finish

2025-01-20

Last updated by the study team

2025-02-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female Veterans between the ages of 18 and 70 years.
• A past-year DSM-5 diagnosis of moderate to severe AUD (i.e., meeting 4 of the 11 DSM-5 criteria for AUD)
• Actively drinking alcohol within the past month ( 2 heavy drinking days, defined as 4 drinks/day for women and 5 drinks/day for men).
• Self-reported insomnia of moderate or severe intensity (i.e., an Insomnia Severity Index total score 15).
• Subject has expressed a desire to stop or reduce drinking.
• Capacity to comprehend and give informed consent.
• Women of child-bearing potential (i.e., who have 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, and have a negative urine pregnancy test prior to initiation of treatment.

You may not qualify if…

• General
• A current, clinically significant physical disease or abnormality based on history, physical examination, or routine laboratory evaluation.
• 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 use disorder other than alcohol, nicotine, cannabis use disorder, or mild stimulant (cocaine) use disorder.
• Untreated subjects with a diagnosis of moderate-severe obstructive sleep apnea with a total Apnea Hypopnea Index (AHI-T) of 15 events/hour of sleep.
• Recent (within the 10 days prior to the baseline visit) exposure to licit or illicit opioids as defined by self-report or a positive urine drug screen. Individuals on a prescription low-dose opioid medication for chronic pain are eligible for treatment with TOP only, and positive urine drug screen(s) will not be exclusionary in this case.
• Patient also agrees not to initiate CBT for alcohol use disorder during the trial or will be discontinued.
• Completed a full course of CBT-I within the past year.
• Specific to Naltrexone treatment
• A history of hypersensitivity to naltrexone.
• A transaminase elevation >300% of normal.
• Active treatment with opioid medications.
• Specific to Topiramate treatment
• A history of hypersensitivity to TOP.
• A history of nephrolithiasis.
• A history of narrow angle glaucoma.
• Current treatment with medications considered a high risk for adverse reactions for TOP treatment, such as carbonic anhydrase inhibitors.

Where it is running

• Coatesville VA Medical Center, Coatesville, PA — Coatesville, Pennsylvania, United States
• Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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