Alcohol DependenceRMETNCT03340051
Remote Alcohol Monitoring and Episodic Thinking
A study testing Episodic Future Thinking (EFT) and Episodic Recent Thinking (ERT) in people with Alcohol Dependence and Alcohol-Related Disorders, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
Nearly 18% of United States adults meet criteria for alcohol dependence sometime in their lifetime, with only 24% of those individuals ever receiving any treatment for their disorder (Hasin et al., 2007). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Dependence, Alcohol-Related Disorders
- What is being tested?
- Episodic Future Thinking (EFT) and Episodic Recent Thinking (ERT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 3 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, 24016
About this study
Official title: Episodic Thinking (ET) as a Candidate Technique to Reduce Alcohol Consumption
Nearly 18% of United States adults meet criteria for alcohol dependence sometime in their lifetime, with only 24% of those individuals ever receiving any treatment for their disorder (Hasin et al., 2007). The pervasiveness of alcohol dependence indicates a need for continued development of high-impact treatments that are both effective and easily disseminated to a broad population. Recent evidence indicates that Episodic Future Thinking (EFT), the ability to self-project and pre-experience a future event, can help individuals to make changes to habitual behaviors, such as alcohol drinking (Snider et al., 2016). In this study, the investigators will evaluate the efficacy of EFT to help individuals reduce alcohol consumption. The investigators anticipate that EFT will result in a reduction in alcohol consumption over a 2-week experimental period when compared to the control group.
Read the 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.
- Conditions
- Alcohol Dependence, Alcohol-Related Disorders
- Being tested
- Episodic Future Thinking (EFT), Episodic Recent Thinking (ERT)
- Medical subject headings
- Alcoholism, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episodic Future Thinking (EFT)Behavioural
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.
Episodic Recent Thinking (ERT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EFT group | Active comparator | 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. Receives: Behavioral: Episodic Future Thinking (EFT) |
| ERT group | Placebo comparator | 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. Receives: Behavioral: Episodic Recent Thinking (ERT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average daily alcohol consumption
Change in average daily alcohol consumption collected using self reports
Measured: 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 outcomes (3)
Change in delay discounting rate
Discounting rates will be measured using adjusting amount delay discounting and minute delay discounting tasks
Measured: 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
Change in intensity of alcohol demand will be determined from an alcohol demand curve generated via an Alcohol Purchase Task (APT)
Measured: 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
Change in elasticity of alcohol demand will be determined from an alcohol demand curve generated via an Alcohol Purchase Task (APT)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start21 Sep 2017
- Primary completion17 Sep 2019
- Study completion3 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen LaConte, Virginia Polytechnic Institute and State University
- Investigators
- Warren K Bickel, PhD, Principal investigator, Virginia Tech Carilion School of Medicine and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340051
- Sponsor's protocol ID
- RMET/15-955
- Acronym
- RMET
- Status last verified
- Feb 2025
- First submitted
- 3 Nov 2017
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Athamneh LN, Brown J, Stein JS, Gatchalian KM, LaConte SM, Bickel WK. Future thinking to decrease real-world drinking in alcohol use disorder: Repairing reinforcer pathology in a randomized proof-of-concept trial. Exp Clin Psychopharmacol. 2022 Jun;30(3):326-337. doi: 10.1037/pha0000460. Epub 2021 Apr 22.
PubMed 35041442
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Episodic Thinking (ET) as a Candidate Technique to Reduce Alcohol Consumption
- ClinicalTrials.gov ID
- NCT03340051
- Acronym / sponsor ID
- RMET / RMET/15-955
- Conditions
- Alcohol Dependence, Alcohol-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 3 Oct 2019 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nearly 18% of United States adults meet criteria for alcohol dependence sometime in their lifetime, with only 24% of those individuals ever receiving any treatment for their disorder (Hasin et al., 2007). The pervasiveness of alcohol dependence indicates a need for continued development of high-impact treatments that are both effective and easily disseminated to a broad population. Recent evidence indicates that Episodic Future Thinking (EFT), the ability to self-project and pre-experience a future event, can help individuals to make changes to habitual behaviors, such as alcohol drinking (Snider et al., 2016). In this study, the investigators will evaluate the efficacy of EFT to help individuals reduce alcohol consumption. The investigators anticipate that EFT will result in a reduction in alcohol consumption over a 2-week experimental period when compared to the control group.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EFT group | Active comparator | Behavioral: Episodic Future Thinking (EFT)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. |
| ERT group | Placebo comparator | Behavioral: Episodic Recent Thinking (ERT)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Episodic Future Thinking (EFT)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. | Behavioural | EFT group |
| Episodic Recent Thinking (ERT)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. | Behavioural | ERT group |
Primary outcome
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
3 secondary outcomes
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
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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 35041442Athamneh LN, Brown J, Stein JS, Gatchalian KM, LaConte SM, Bickel WK. Future thinking to decrease real-world drinking in alcohol use disorder: Repairing reinforcer pathology in a randomized proof-of-concept trial. Exp Clin Psychopharmacol. 2022 Jun;30(3):326-337. doi: 10.1037/pha0000460. Epub 2021 Apr 22.
- 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.
Warren K Bickel, PhD principal investigator
Virginia Tech Carilion School of Medicine and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Episodic Future Thinking (EFT) and Episodic Recent Thinking (ERT) in people with Alcohol Dependence and Alcohol-Related Disorders, run by Virginia Polytechnic Institute and State University 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 7 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 12 Feb 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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).). 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 NCT03340051, which also lists 1 linked publication.
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 12 Feb 2025.