Alcohol Use DisorderPhase 2NCT03424681
Modafinil for the Treatment of Alcohol Use Disorders
A Phase 2 study testing Modafinil in people with Alcohol Use Disorder, run by The Mind Research Network at 1 site in United States.
Trial summary
Alcohol use disorder (AUD) is a major cause of morbidity and mortality and more treatments are needed, especially pharmacotherapies. There are a variety of efficacious treatments for AUD, but effect sizes are small, and vary from study to study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 31 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females age 18-65 meeting Diagnostic and Statistical Manual V criteria for moderate or severe AUD in the past year
- Interested in cutting down or quitting
- 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 60 days
- Stop signal reaction time on a stop signal task>233
Who cannot join
- Severe neurological conditions (severe traumatic brain injury/stroke/active seizure disorder)
- Heart disease [mitral valve prolapse, left ventricular hypertrophy, cardiac arrhythmias, angina, myocardial infarction, unstable angina, cardiac syncope or pre-syncope, any electrocardiogram (ECG) finding that suggests the presence of one of these conditions]
- Uncontrolled hypertension (systolic blood pressure >160, diastolic blood pressure >100)
- Heart rate greater than 70% of the maximum expected for age [0.70(220-age)]
- Chronic renal or hepatic failure
- Recent pancreatitis
Show all 15Show fewer
- Insulin-dependent diabetes
- Other urgent medical problems
- Elevated liver function tests (AST or ALT greater than 4 times normal; modafinil is metabolized primarily by the liver)
- 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
- Current daily use of anti-craving medications, stimulants, benzodiazepines, opiates, anti-psychotics; current daily use of tricyclic antidepressants, bupropion, monoamine oxidase inhibitors, serotonin and norepinephrine reuptake inhibitors, or therapeutic doses (for bipolar disorder) of mood stabilizers
- Taking a medication contraindicated for use with modafinil
Trial locations and contacts
1 site in 1 country.
United States1 site
Mind Research Network
Albuquerque, New Mexico, 87106
About this study
Official title: Modafinil for the Treatment of Alcohol Use Disorders: Targeting Impaired Response Inhibition
Alcohol use disorder (AUD) is a major cause of morbidity and mortality and more treatments are needed, especially pharmacotherapies. There are a variety of efficacious treatments for AUD, but effect sizes are small, and vary from study to study. Medications may be more effective if particular subgroups of AUD are targeted. Identifying the mechanisms of action of a particular medication will help identify the subtypes more likely to respond to therapy. Global impulse control is a rational treatment target, and improving it is a likely mechanisms by which some medications for AUD work, especially in subtypes of AUD with impaired impulse control at baseline. Modafinil is a medication that is FDA approved for the treatment of narcolepsy, and is relatively safe and tolerable. There is reason to believe it may improve impulse control, and underlying neural circuitry, and may work best to improve alcohol use outcomes in AUD with poor impulse control. The overall aim of this study is to investigate the effects of modafinil on task performance and the integrity of neural circuits mediating response inhibition in treatment-seeking AUD with poor response inhibition, to establish target engagement. Secondary aims are to measure whether target engagement mediates improvement in alcohol use outcomes, and to utilize machine learning to identify neural and behavioral markers which best predict treatment outcomes. Twenty-four individuals with AUD and impaired response inhibition will be enrolled in the study, randomized to modafinil or placebo, and treated for 6 weeks. Functional magnetic resonance imaging brain scans during a response inhibition task and during rest will be obtained at baseline and 2 weeks. Aversive stimuli will be included in the response inhibition task to assure that efficacy generalizes to several conditions. Diffusion imaging and arterial spin labeling sequences will also be obtained. Investigators predict that modafinil will significantly increase brain activity in the medial and lateral prefrontal cortex during response inhibition, thereby establishing target engagement, and that it will improve alcohol use outcomes. Findings will provide information about whether or not a larger R01 trial investigating the efficacy of modafinil for individuals with AUD and impaired response inhibition is warranted.
Read the detailed description
see above.
- Conditions
- Alcohol Use Disorder
- Being tested
- Modafinil, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
Also called Provigil
Modafinil 300 mg by mouth daily
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Modafinil | Experimental | Modafinil 300 mg by mouth each day Receives: Drug: Modafinil |
| Placebo | Placebo comparator | Identical looking capsule/number of capsules by mouth each day without active medication Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Relapse
Time to relapse, starting 7 days after treatment initiation (after medication has reached maximum tolerated dose), to heavy drinking days (>4 standard drinks for men, >3 standard drinks for women); abstinent is coded as 9*7=63; dropout not included
Measured: over 9 weeks
Secondary outcomes (3)
Drinks Per Drinking Day
drinks per drinking day weeks 4-6
Measured: Weeks 4-6
Drinks Per Week
drinks per week weeks 4-6
Measured: Weeks 4-6
Percent Days Abstinent
percent days abstinent weeks 4-6
Measured: Weeks 4-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start11 Dec 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Mind Research Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Wilcox, The Mind Research Network
- Investigators
- Claire Wilcox, MD, Principal investigator, Mind Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424681
- Sponsor's protocol ID
- FP00002746
- Status last verified
- May 2020
- First submitted
- 4 Jan 2018
- Last updated
- 26 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modafinil for the Treatment of Alcohol Use Disorders: Targeting Impaired Response Inhibition
- ClinicalTrials.gov ID
- NCT03424681
- Acronym / sponsor ID
- FP00002746
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Mind Research NetworkUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Posted 26 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alcohol use disorder (AUD) is a major cause of morbidity and mortality and more treatments are needed, especially pharmacotherapies. There are a variety of efficacious treatments for AUD, but effect sizes are small, and vary from study to study. Medications may be more effective if particular subgroups of AUD are targeted. Identifying the mechanisms of action of a particular medication will help identify the subtypes more likely to respond to therapy. Global impulse control is a rational treatment target, and improving it is a likely mechanisms by which some medications for AUD work, especially in subtypes of AUD with impaired impulse control at baseline. Modafinil is a medication that is FDA approved for the treatment of narcolepsy, and is relatively safe and tolerable. There is reason to believe it may improve impulse control, and underlying neural circuitry, and may work best to improve alcohol use outcomes in AUD with poor impulse control. The overall aim of this study is to investigate the effects of modafinil on task performance and the integrity of neural circuits mediating response inhibition in treatment-seeking AUD with poor response inhibition, to establish target engagement. Secondary aims are to measure whether target engagement mediates improvement in alcohol use outcomes, and to utilize machine learning to identify neural and behavioral markers which best predict treatment outcomes. Twenty-four individuals with AUD and impaired response inhibition will be enrolled in the study, randomized to modafinil or placebo, and treated for 6 weeks. Functional magnetic resonance imaging brain scans during a response inhibition task and during rest will be obtained at baseline and 2 weeks. Aversive stimuli will be included in the response inhibition task to assure that efficacy generalizes to several conditions. Diffusion imaging and arterial spin labeling sequences will also be obtained. Investigators predict that modafinil will significantly increase brain activity in the medial and lateral prefrontal cortex during response inhibition, thereby establishing target engagement, and that it will improve alcohol use outcomes. Findings will provide information about whether or not a larger R01 trial investigating the efficacy of modafinil for individuals with AUD and impaired response inhibition is warranted.
Detailed description
see above.
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 |
|---|---|---|
| Modafinil | Experimental | Drug: ModafinilModafinil 300 mg by mouth each day |
| Placebo | Placebo comparator | Other: PlaceboIdentical looking capsule/number of capsules by mouth each day without active medication |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females age 18-65 meeting Diagnostic and Statistical Manual V criteria for moderate or severe AUD in the past year
- Interested in cutting down or quitting
- 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 60 days
- Stop signal reaction time on a stop signal task>233
Key exclusion criteria (15 listed)
- Severe neurological conditions (severe traumatic brain injury/stroke/active seizure disorder)
- Heart disease [mitral valve prolapse, left ventricular hypertrophy, cardiac arrhythmias, angina, myocardial infarction, unstable angina, cardiac syncope or pre-syncope, any electrocardiogram (ECG) finding that suggests the presence of one of these conditions]
- Uncontrolled hypertension (systolic blood pressure >160, diastolic blood pressure >100)
- Heart rate greater than 70% of the maximum expected for age [0.70(220-age)]
- Chronic renal or hepatic failure
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 |
|---|---|---|
| ModafinilAlso: ProvigilModafinil 300 mg by mouth daily | Drug | Modafinil |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Time to Relapse
Time frame: over 9 weeks
Time to relapse, starting 7 days after treatment initiation (after medication has reached maximum tolerated dose), to heavy drinking days (>4 standard drinks for men, >3 standard drinks for women); abstinent is coded as 9*7=63; dropout not included
3 secondary outcomes
Drinks Per Drinking Day
Time frame: Weeks 4-6
Drinks Per Week
Time frame: Weeks 4-6
Percent Days Abstinent
Time frame: Weeks 4-6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- 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.
Claire Wilcox, MD principal investigator
Mind Research Network
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 Modafinil 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 5 inclusion and 15 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 May 2020. 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 May 2020). 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?
Time to Relapse (time frame: over 9 weeks). 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 May 2020.