Health TrialsbyHealthPanel

Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking

ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOhio State University

About this trial

The goal of this clinical trial is to learn if, how, and for whom suvorexant (SUV) works to treat alcohol use disorder (AUD). The main questions it aims to answer are:

* Is SUV effective for AUD? * Does SUV dampen stress reactivity? * Can the researchers develop a biomarker for SUV treatment response?

Researchers will compare SUV to a placebo (a look-alike substance that contains no drug) to see if drug SUV works to treat AUD.

Participants will:

* Take 10mg capsules of SUV or a placebo orally each night before bedtime for 8-weeks. * Visit the laboratory before (baseline), 4-weeks (mid-point), and 8-weeks (end-point) after taking SUV or placebo that include the psychophysiological stress paradigm (electromyography; EMG). * Complete daily reports of medication adherence, side-effects, sleep, alcohol use, and mood will be collected via smartphones during the 8-week medication trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Generally medically and neurologically healthy;

Age 18 to 65 at the time of consent;

Willing and able to give informed consent;

Current DSM-5 diagnosis of moderate to severe alcohol use disorder;

Disqualifiers

Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function, and/or task performance, and/or interfere with the study protocol, and/or be contraindicated for suvorexant including sleep disorders (e.g., narcolepsy; severe obstructive sleep apnea), hepatic impairment, compromised respiratory function, renal impairment, and endocrine disorders;

Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;

Current substance use disorder (SUD) other than alcohol or mild cannabis use disorder;

Currently pregnant (positive pregnancy test), lactating, or not agreeing to use birth control methods during the duration of the trial (women);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Suvorexant 10 mg

    Drug

    This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment, mid-treatment, and post-treatment lab visits. Suvorexant (SUV) will be placed in opaque capsules with dextrose filler. Following the pre-treatment visit, participants will receive a labeled blister pack with 28 pills and be instructed to take one pill orally about 30 minutes prior to sleep time each night for 4 weeks. Participants will be provided education about common side effects. At the end of the 4-weeks, participants will return to the lab to complete a mid-treatment lab visit, receive a second labeled blister pack, and will be instructed to continue taking one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will return to complete a post-treatment lab visit. Participants will complete daily surveys to monitor side effects throughout the 8-week medication trial.

  • Placebo

    Other intervention

    This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment, mid-treatment, and post-treatment lab visits. The placebo pill will be identical in appearance to suvorexant but will contain only dextrose. Following the pre-treatment visit, participants will receive a labeled blister pack with 28 pills and be instructed to take one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will be provided education about common side effects. At the end of the 4-weeks, participants will return to the lab to complete a mid-treatment lab visit, receive a second labeled blister pack, and will be instructed to continue taking one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will return to complete a post-treatment lab visit. Participants will complete daily surveys to monitor side effects throughout the 8-week medication trial.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: ControlPlacebo comparator 1 intervention
Group B: SuvorexantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Heavy Drinking Days

Self-reported heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measured as proportion of heavy drinking days.

Time frame
8-week treatment period
2

Startle eyeblink potentiation

Startle eyeblink potentiation will be collected during the NPU threat task that is administered at all three lab sessions. Startle is a cross-species index of aversive reactivity.

Time frame
Baseline; 4-weeks; 8-weeks
3

Alcohol Craving Via Ecological Momentary Assessment (EMA)

Participants will rate the intensity of their alcohol cravings using a Likert scale of 1 (lowest craving) -7 (highest craving).

Time frame
8-week treatment period

Secondary outcomes

1

Drinks Per Day

Self-reported total number of alcoholic drinks per day of the trial.

Time frame
8-week treatment period
2

Proportion of Days Abstinent

Self-reported proportion of days that individuals were abstinent from alcohol use.

Time frame
8-week treatment period
3

Transdermal Alcohol Concentration (TAC)

Participants' TAC will provide an objective estimate of alcohol consumption each day.

Time frame
8-week treatment period
4

Phosphatidylethanol (PEth) levels

PEth will be measured from plasma samples at the mid-point and end-point. PEth is an objective biomarker of recent alcohol consumption.

Time frame
4-weeks; 8-weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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