Alcohol Use Disorder (AUD)Phase 2NCT04229095
Medication Development in Alcoholism: Suvorexant Versus Placebo
A Phase 2 study testing Suvorexant 20 mg in people with Alcohol Use Disorder (AUD), run by The Scripps Research Institute at 1 site in United States.
Trial summary
The primary hypotheses under test are that alcohol dependent subjects treated with suvorexant will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Suvorexant 20 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2021to 8 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female volunteers, 18-65 years of age.
- Meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for current alcohol use disorder of moderate or greater severity (AUD-MS).
- In the month prior to screening, reports drinking ≥ 21 standard drinks per week if male, ≥ 14 if female, with at least one heavy drinking day (≥ 5 males, ≥ 4 females) per week.
- Subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues
- Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session.
- Negative blood alcohol content (BAC) and a Clinical Institute Withdrawal Assessment (CIWA) score of < 9 at time of randomization and lab session to eliminate acute alcohol or withdrawal effects on dependent measures.
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- In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, EKG, routine urine and blood chemistry.
- Subjects with a history of depression, who have been on a stable dose of anti-depressant medication for at least 3 months, and do not meet current DSM-5 criteria for depression or anxiety.
- Females with childbearing potential must have a negative pregnancy test on the screening and randomization visits and agree to use effective birth control for the duration required by a given study.
- Able to provide informed consent and understand questionnaires and study procedures in English.
- Willing to comply with the provisions of the protocol and take oral medication.
Who cannot join
- Meets DSM-5 criteria for a major psychiatric disorder, including mood or anxiety disorders or substance use disorders other than alcohol or nicotine, or, mild cannabis use disorder
- Has a urine drug screen (UDS) positive for substances of abuse other than alcohol or marijuana
- Significant medical disorders that will increase potential risk or interfere with study participation as determined by the study physician.
- Liver function tests more than 3 times the upper limit of normal or elevated bilirubin.
- Subjects taking digoxin or CYP3A inhibitors or inducers, metabolism by CYP3A is the major elimination pathway for suvorexant.
- Treatment within the month prior to screening with (1) an investigational drug, (2) medications which may negatively interact with study medications, or (3) drugs that may influence study outcomes (e.g., disulfiram [Antabuse], naltrexone [ReVia], acamprosate [Campral], or anticonvulsants).
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- Ongoing treatment with medications that may increase risk, including prescribed, over-the-counter, and herbal preparations, as determined by the study physician.
- Sexually active female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective methods of birth control for the duration of the study.
- No fixed domicile and/or no availability by home or mobile telephone.
- History of hypersensitivity to the study drug or the ingredients.
- Failure to take double-blind medication as prescribed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medication Development for Protracted Abstinence in Alcoholism: Suvorexant Versus Placebo
The primary hypotheses under test are that alcohol dependent subjects treated with suvorexant will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo. Suvorexant (Belsomra®) received approval by the FDA in 2014 for treatment of insomnia. To control for any effect of pre-existing sleep disturbance for which suvorexant may be indicated, subjects will be stratified on the basis of a Pittsburgh Sleep Quality Index total score of > 5 versus <5. Subjects were also stratified by sex.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Suvorexant 20 mg, Placebo oral tablet
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suvorexant 20 mgDrug
Also called Belsomra
Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit
Placebo oral tabletDrug
Also called Sugar pill
Single-dose administration of placebo given on an inpatient clinical research unit
| Study group | Role | What they receive |
|---|---|---|
| Belsomra,(suvorexant) | Active comparator | 20 mg single-dose administration given on an inpatient clinical research unit Receives: Drug: Suvorexant 20 mg |
| Placebo | Placebo comparator | Placebo single-dose administration given on an inpatient clinical research unit Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) of Craving Severity: 2 Arms
VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.
Measured: 1 hour during cue reactivity session
Visual Analog Scale (VAS) Strength of Craving: Combined Arms Conditional Model
VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.
Measured: 1 hour during cue reactivity session
Secondary outcomes (2)
Number of Standard Drinks Per Day: 2 Arms
Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcohol drinks consumed per day with a minimum value of 0 and an undetermined maximum value
Measured: Up to one week following single dose administration
Number of Standard Drinks Per Day: Combined Arms Conditional Model
Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value.
Measured: Up to one week following single dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start17 Nov 2021
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment, Double-Blind, Randomized Stratified at randomization based on sex and Pittsburgh Sleep Quality Index Total Score (PSQI) greater than or equal to 5 versus less than 5.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Scripps Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Barbara J. Mason, Ph.D., Principal investigator, The Scripps Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229095
- Sponsor's protocol ID
- P60AA006420
- Other IDs
- P60AA006420
- Status last verified
- Apr 2023
- First submitted
- 9 Jan 2020
- Last updated
- 26 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Development for Protracted Abstinence in Alcoholism: Suvorexant Versus Placebo
- ClinicalTrials.gov ID
- NCT04229095
- Acronym / sponsor ID
- P60AA006420
- Conditions
- Alcohol Use Disorder (AUD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- The Scripps Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Posted 26 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary hypotheses under test are that alcohol dependent subjects treated with suvorexant will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo. Suvorexant (Belsomra®) received approval by the FDA in 2014 for treatment of insomnia. To control for any effect of pre-existing sleep disturbance for which suvorexant may be indicated, subjects will be stratified on the basis of a Pittsburgh Sleep Quality Index total score of > 5 versus <5. Subjects were also stratified by sex.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment, Double-Blind, Randomized Stratified at randomization based on sex and Pittsburgh Sleep Quality Index Total Score (PSQI) greater than or equal to 5 versus less than 5.
| Arm | Type | Receives |
|---|---|---|
| Belsomra,(suvorexant) | Active comparator | Drug: Suvorexant 20 mg20 mg single-dose administration given on an inpatient clinical research unit |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo single-dose administration given on an inpatient clinical research unit |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female volunteers, 18-65 years of age.
- Meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for current alcohol use disorder of moderate or greater severity (AUD-MS).
- In the month prior to screening, reports drinking ≥ 21 standard drinks per week if male, ≥ 14 if female, with at least one heavy drinking day (≥ 5 males, ≥ 4 females) per week.
- Subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues
- Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session.
Key exclusion criteria (11 listed)
- Meets DSM-5 criteria for a major psychiatric disorder, including mood or anxiety disorders or substance use disorders other than alcohol or nicotine, or, mild cannabis use disorder
- Has a urine drug screen (UDS) positive for substances of abuse other than alcohol or marijuana
- Significant medical disorders that will increase potential risk or interfere with study participation as determined by the study physician.
- Liver function tests more than 3 times the upper limit of normal or elevated bilirubin.
- Subjects taking digoxin or CYP3A inhibitors or inducers, metabolism by CYP3A is the major elimination pathway for suvorexant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suvorexant 20 mgAlso: BelsomraSingle-dose administration of 20 mg suvorexant given on an inpatient clinical research unit | Drug | Belsomra,(suvorexant) |
| Placebo oral tabletAlso: Sugar pillSingle-dose administration of placebo given on an inpatient clinical research unit | Drug | Placebo |
Primary outcome
Visual Analogue Scale (VAS) of Craving Severity: 2 Arms
Time frame: 1 hour during cue reactivity session
VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.
Visual Analog Scale (VAS) Strength of Craving: Combined Arms Conditional Model
Time frame: 1 hour during cue reactivity session
VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.
2 secondary outcomes
Number of Standard Drinks Per Day: 2 Arms
Time frame: Up to one week following single dose administration
Number of Standard Drinks Per Day: Combined Arms Conditional Model
Time frame: Up to one week following single dose administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara J. Mason, Ph.D. principal investigator
The Scripps Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Suvorexant 20 mg in people with Alcohol Use Disorder (AUD), run by The Scripps Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) of Craving Severity: 2 Arms (time frame: 1 hour during cue reactivity session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.