Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT04581603
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04581603
Study Brief:
Protocol Section:
NCT04581603