Alcohol Use DisorderPhase 2NCT03539432

Exploration of Gemfibrozil as a Treatment for AUD

A Phase 2 study testing Gemfibrozil 600 MG in people with Alcohol Use Disorder, run by The Mind Research Network at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Alcohol Use Disorder
What is being tested?: Gemfibrozil 600 MG
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3 participants
Where: 1 siteUnited States
Study dates: 16 May 2018to 30 Dec 2018
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

males and females age 18-60 meeting DSM-V criteria for moderate or severe AUD in the past year
interested in cutting down or quitting drinking
able to provide voluntary informed consent
have at least 4 heavy drinking days (≥ 5 drinks per day for men, and 4 for women) in the past 30 days

Who cannot join

severe liver disease; severe kidney disease; gallbladder disease or gallstones
chronic renal or hepatic failure
recent pancreatitis
insulin-dependent diabetes
other urgent medical problems
moderately elevated liver function tests (AST or ALT greater than 2 times upper limit of normal) or elevated creatine kinase (CK)

Show all 16Show fewer

schizophrenia, schizoaffective disorder, Bipolar I disorder, suicidal thoughts in the last month
current moderate or severe other substance use disorder (SUD; except nicotine or marijuana)
active legal problems with the potential to result in incarceration
pregnancy or lactation, or child bearing age and not on birth control or not willing to use other birth control methods (e.g. condoms)
current daily use of anti-craving medications, mood stabilizers, benzodiazepines, or anti-psychotics
regularly taking a medication contraindicated for use with gemfibrozil including other fibrates, statins, repaglinide, or which are believed to interact with gemfibrozil such as dasabuvir, dabrafenib, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone, colestipol, colchicine and warfarin41,68
a history of alcohol withdrawal-induced seizures or delirium tremens (hallucinations, disorientation) requiring hospital admission during the last ten years
a history of moderate or severe traumatic brain injury (TBI; loss of consciousness >30 minutes69)
left-handedness
any contraindications for MRI

Trial locations and contacts

1 site in 1 country.

United States1 site

The Mind Research Network
Albuquerque, New Mexico, 87106

Other trials in United States

About this study

Official title: Exploration of Gemfibrozil as a Treatment for Alcohol Use Disorder

This study will examine the efficacy of the medication gemfibrozil in reducing alcohol consumption in individuals with an alcohol use disorder who are seeking treatment for alcohol-related problems. Twenty individuals will be randomized to receive four weeks of either gemfibrozil or placebo and retrospective reports of alcohol use will be collected throughout the trial. In addition, brain imaging measures will be collected at baseline and after two weeks of treatment to determine the effects of gemfibrozil on brain functioning.

Conditions: Alcohol Use Disorder
Being tested: Gemfibrozil 600 MG, Placebo oral capsule
Medical subject headings: Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gemfibrozil 600 MGDrug
Gemfibrozil capsules (600 mg) taken twice per day
Placebo oral capsuleDrug
Microcrystalline cellulose powder packaged in capsules identical to the experimental medication

Study groups in NCT03539432
Study group	Role	What they receive
Gemfibrozil	Experimental	Gemfibrozil 600 mg by mouth twice daily Receives: Drug: Gemfibrozil 600 MG
Placebo	Placebo comparator	Microcrystalline cellulose powder packaged in capsules identical to the experimental condition Receives: Drug: Placebo oral capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Standard Drinks Per Drinking Day
Average number of standard drinks consumed on drinking days
Measured: Baseline
Mean Standard Drinks Per Drinking Day
Average number of standard drinks consumed on drinking days
Measured: 2 weeks post baseline
Mean Standard Drinks Per Drinking Day
Average number of standard drinks consumed on drinking days
Measured: 4 weeks post baseline
Percent Days Abstinent
Percentage of days of abstinence from alcohol
Measured: Baseline
Percent Days Abstinent
Percentage of days of abstinence from alcohol
Measured: 2 weeks post baseline
Percent Days Abstinent
Percentage of days of abstinence from alcohol
Measured: 4 weeks post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 201830 Dec 2018

First posted29 May 2018
Study start16 May 2018
Primary completion30 Dec 2018
Study completion30 Dec 2018

Why it stopped: Funds for the study expired

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 DisorderStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03539432
Sponsor's protocol ID: 20-018
Status last verified: Sep 2021
First submitted: 16 May 2018
Last updated: 29 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploration of Gemfibrozil as a Treatment for Alcohol Use Disorder
ClinicalTrials.gov ID: NCT03539432
Acronym / sponsor ID: 20-018
Conditions: Alcohol Use Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funds for the study expired
Enrolment: 3 participants (actual)
Lead sponsor: The Mind Research NetworkUniversity, hospital or other
Study start: 16 May 2018 (actual)
Primary completion: 30 Dec 2018 (actual)
Study completion: 30 Dec 2018 (actual)
First posted: 29 May 2018 (actual)
Results: Posted 18 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Gemfibrozil	Experimental	Drug: Gemfibrozil 600 MGGemfibrozil 600 mg by mouth twice daily
Placebo	Placebo comparator	Drug: Placebo oral capsuleMicrocrystalline cellulose powder packaged in capsules identical to the experimental condition

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

males and females age 18-60 meeting DSM-V criteria for moderate or severe AUD in the past year
interested in cutting down or quitting drinking
able to provide voluntary informed consent
have at least 4 heavy drinking days (≥ 5 drinks per day for men, and 4 for women) in the past 30 days

Key exclusion criteria (16 listed)

severe liver disease; severe kidney disease; gallbladder disease or gallstones
chronic renal or hepatic failure
recent pancreatitis
insulin-dependent diabetes
other urgent medical problems

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
Gemfibrozil 600 MGGemfibrozil capsules (600 mg) taken twice per day	Drug	Gemfibrozil
Placebo oral capsuleMicrocrystalline cellulose powder packaged in capsules identical to the experimental medication	Drug	Placebo

Primary outcome

Mean Standard Drinks Per Drinking Day
Time frame: Baseline
Average number of standard drinks consumed on drinking days
Mean Standard Drinks Per Drinking Day
Time frame: 2 weeks post baseline
Average number of standard drinks consumed on drinking days
Mean Standard Drinks Per Drinking Day
Time frame: 4 weeks post baseline
Average number of standard drinks consumed on drinking days
Percent Days Abstinent
Time frame: Baseline
Percentage of days of abstinence from alcohol
Percent Days Abstinent
Time frame: 2 weeks post baseline
Percentage of days of abstinence from alcohol
Percent Days Abstinent
Time frame: 4 weeks post baseline
Percentage of days of abstinence from alcohol

Results and safety

Results posted to the registry on 18 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gemfibrozil	2	2
Placebo	1	0

Primary outcome: Mean Standard Drinks Per Drinking Day

Time frame: Baseline. Mean (Full Range). Unit: Drinks per drinking day

Measure	Gemfibrozil n = 2	Placebo n = 1
Value	6.17 (5.57 to 6.76)	8.59 (8.59 to 8.59)

Primary outcome: Mean Standard Drinks Per Drinking Day

Time frame: 2 weeks post baseline. Mean (Full Range). Unit: Drinks per drinking day

Measure	Gemfibrozil n = 2	Placebo n = 0
Value	4.12 (3.58 to 4.667)	–

Population analysed: The one participant in the placebo condition dropped out before taking any medication

Primary outcome: Mean Standard Drinks Per Drinking Day

Time frame: 4 weeks post baseline. Mean (Full Range). Unit: Drinks per drinking day

Measure	Gemfibrozil n = 2	Placebo n = 0
Value	2.18 (2 to 2.35)	–

Population analysed: The one participant in the placebo condition dropped out before taking any medication

Primary outcome: Percent Days Abstinent

Time frame: Baseline. Mean (Full Range). Unit: Percentage of abstinent days

Measure	Gemfibrozil n = 2	Placebo n = 1
Value	31 (16.7 to 44.4)	32.2 (32.2 to 32.2)

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gemfibrozil	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Placebo	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
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.

The record lists no contact. Use the official record to reach the sponsor.

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 Gemfibrozil 600 MG in people with Alcohol Use Disorder, run by The Mind Research Network 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 4 inclusion and 16 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: stopped early, as of the sponsor's last update on 29 Oct 2021. 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 18 Oct 2021). 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?

Mean Standard Drinks Per Drinking Day (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03539432.

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 29 Oct 2021.