Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03424681
Other study ID # FP00002746
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 11, 2017
Est. completion date August 31, 2018

Study information

Verified date May 2020
Source The Mind Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

see above.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date August 31, 2018
Est. primary completion date August 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Modafinil
Modafinil 300 mg by mouth daily
Other:
Placebo
Placebo

Locations

Country Name City State
United States Mind Research Network Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
The Mind Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 over 9 weeks
Secondary Drinks Per Drinking Day drinks per drinking day weeks 4-6 Weeks 4-6
Secondary Drinks Per Week drinks per week weeks 4-6 Weeks 4-6
Secondary Percent Days Abstinent percent days abstinent weeks 4-6 Weeks 4-6
See also
  Status Clinical Trial Phase
Recruiting NCT04788004 - Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
Recruiting NCT05684094 - Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function N/A
Completed NCT03406039 - Testing the Efficacy of an Online Integrated Treatment for Comorbid Alcohol Misuse and Emotional Problems N/A
Completed NCT03573167 - Mobile Phone-Based Motivational Interviewing in Kenya N/A
Completed NCT04817410 - ED Initiated Oral Naltrexone for AUD Phase 1
Active, not recruiting NCT04267692 - Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders N/A
Completed NCT03872128 - The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders Phase 1
Completed NCT02989662 - INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers Phase 1/Phase 2
Recruiting NCT06030154 - Amplification of Positivity for Alcohol Use N/A
Active, not recruiting NCT05419128 - Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19 N/A
Completed NCT04564807 - Testing an Online Insomnia Intervention N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT04203966 - Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
Recruiting NCT05861843 - Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
Terminated NCT04404712 - FAAH Availability in Psychiatric Disorders: A PET Study Early Phase 1
Enrolling by invitation NCT04128761 - Decreasing the Temporal Window in Individuals With Alcohol Use Disorder N/A
Not yet recruiting NCT06337721 - Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults N/A
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Not yet recruiting NCT06444243 - Psilocybin-assisted Therapy for Alcohol Use Disorder Phase 2
Enrolling by invitation NCT02544581 - Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare N/A