- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03340051
Remote Alcohol Monitoring and Episodic Thinking (RMET)
Episodic Thinking (ET) as a Candidate Technique to Reduce Alcohol Consumption
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After the initial consent and assessment sessions, participants will be asked to provide daily self-report assessments of previous-day drinking over cell phone for 7 days with no other study intervention taking place. The purpose for this baseline period is to quantify baseline drinking patterns and ensure that the participant reliably responds to and conveys study information via cell phone. At the end of this baseline period, participants who indicated adaquate patterns of drinking and successfully reported their level of drinking will be invited to continue in the study. Participants will return to the laboratory to be provided with a SOBERLINK breathalyzer and be given instruction in its use. The SOBERLINK device will automatically upload breathalyzer results, the participant's location, and the picture of the user to a centralized, secure website where the data will be available to research staff.
Participants will be counterbalanced to either the active or control group based on alcohol use (e.g., average drinks per day). Both groups will be exposed to the same treatment events. The intervention period will last for 14 consecutive days, with three breathalyzer screens per day. During this 14-day period as they did during the baseline period, participants will self-report their previous-day alcohol use daily with a text message and/or phone call. Assessment sessions will be conducted prior to the intervention, immediately following the intervention, and at a 1-month follow-up.
All participants will either be allowed to use their own personal cell phone for study communications or receive a prepaid cell phone with service through a nationwide cell phone service provider. The study-provided phones include usage controls, allowing us to restrict phone communication to a study phone and 911 service.
Throughout the intervention phase of the experiment, participants will be required to submit three daily breathalyzer assessments at the predetermined times. They will be reminded via text message when a sample is to be collected, and samples will be accepted up to 15 minutes before the scheduled time and 30-60 minutes after the scheduled time, giving the participant 45-75 minutes total to submit the sample.
Participants will be assigned to either the active Episodic Future Thinking (EFT) condition or the control Episodic Recent Thinking (ERT) condition. EFT participants will generate positive future events they are looking forward to and that could happen at different future time points (e.g., in 2 weeks, 1 month, 6 months, 1 year) and participants in the ERT condition will list positive recent events (events that have already happened) that they enjoyed that occurred at different past time points (e.g., 12 hours ago, 24 hours ago,1 week ago). Participants will be instructed to use and think about their episodic cues as they make decisions. All participants will be provided with a copy of their episodic cues to take home with them and will receive periodic text messages from research staff to remind them of their cues. In addition, each day, participants will be asked to report how many alcoholic drinks they consumed the previous day (from the time they awoke to the time they fell asleep). Participants will be allowed to report this information via text message or phone call. Participants will receive a reminder to report their previous-day drinking with text messages, followed by a phone call if they haven't contacted us by early evening.
Assessment sessions will be completed before the 14-day intervention period, immediately after the 14-day intervention period, and at a 1-month follow-up. Participants will complete a battery of questionnaires and tasks grouped into three general categories: measures of substance use (including a urine test for drug use and a breath sample to test for recent alcohol use), clinically relevant measures including treatment acceptability, and measures of alcohol value and sensitivity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Fralin Biomedical Research Institute at VTC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- provide written informed consent
- be 18-65 years old
- meet DSM-V criteria for moderate or severe alcohol use disorder
- express a desire to quit or cut down on their drinking.
Exclusion Criteria:
Individuals who are:
- pregnant or lactating
- meet DSM-V criteria for any other moderate or severe substance use disorders (excluding caffeine, nicotine, and marijuana),
- score 23 or greater on the Alcohol Withdrawal Symptom Checklist (a score indicating that medication would be likely required to manage alcohol detoxification)
- use prescribed or over-the-counter medicines containing alcohol
- participated in any previous studies that included EFT at the Addiction Recovery Research Center in the last three months
- have immediate plans to move out of the area
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: EFT group
Episodic Future Thinking (EFT) is the intervention in this arm.
EFT participants will generate positive future events they are looking forward to and that could happen at different future time points (e.g., in 2 weeks, 1 month, 6 months, 1 year).
Participants will be instructed to use and think about their episodic cues as they make decisions.
|
EFT participants will generate positive future events they are looking forward to and that could happen at different future time points (e.g., in 2 weeks, 1 month, 6 months, 1 year).
Participants will be instructed to use and think about their episodic cues as they make decisions.
|
PLACEBO_COMPARATOR: ERT group
Episodic Recent Thinking (ERT) is the intervention in this arm.
ERT participants will list positive recent events (events that have already happened) that they enjoyed that occurred at different past time points (e.g., 12 hours ago, 24 hours ago, a week ago).
Participants will be instructed to use and think about their episodic cues as they make decisions.
|
ERT participants will list positive recent events (events that have already happened) that they enjoyed that occurred at different past time points (e.g., 12 hours ago, 24 hours ago, a week ago).
Participants will be instructed to use and think about their episodic cues as they make decisions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in average daily alcohol consumption
Time Frame: Self report of daily alcohol use will be collected every morning for 7 days after the first session (baseline measure) and for 14 days after the second session and the averages of the 7- and 14-day periods will be compared (pre-post intervention).
|
Change in average daily alcohol consumption collected using self reports
|
Self report of daily alcohol use will be collected every morning for 7 days after the first session (baseline measure) and for 14 days after the second session and the averages of the 7- and 14-day periods will be compared (pre-post intervention).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in delay discounting rate
Time Frame: At the first session (baseline measures), third session (after 3 weeks/post-intervention), and the 1 month follow up assessments. The average discounting rates within each group will be compared pre-post intervention
|
Discounting rates will be measured using adjusting amount delay discounting and minute delay discounting tasks
|
At the first session (baseline measures), third session (after 3 weeks/post-intervention), and the 1 month follow up assessments. The average discounting rates within each group will be compared pre-post intervention
|
Change in intensity of alcohol demand
Time Frame: At the first session (baseline measures), third (after 3 weeks/post-intervention), and the 1 month follow up assessments. The average scores within each group will be compared pre-post intervention
|
Change in intensity of alcohol demand will be determined from an alcohol demand curve generated via an Alcohol Purchase Task (APT)
|
At the first session (baseline measures), third (after 3 weeks/post-intervention), and the 1 month follow up assessments. The average scores within each group will be compared pre-post intervention
|
Change in elasticity of alcohol demand
Time Frame: At the first session (baseline measures), third (after 3 weeks/post-intervention), and the 1 month follow up assessments. The average scores within each group will be compared pre-post intervention
|
Change in elasticity of alcohol demand will be determined from an alcohol demand curve generated via an Alcohol Purchase Task (APT)
|
At the first session (baseline measures), third (after 3 weeks/post-intervention), and the 1 month follow up assessments. The average scores within each group will be compared pre-post intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Warren K Bickel, PhD, Virginia Tech Carilion School of Medicine and Research Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMET/15-955
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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