ClinicalTrials.gg
CompletedNCT03340051RMETUpdated Feb 12, 2025

Remote Alcohol Monitoring and Episodic Thinking

An interventional study of Episodic Future Thinking (EFT) and Episodic Recent Thinking (ERT) in Alcohol Dependence and Alcohol-Related Disorders, sponsored by Virginia Polytechnic Institute and State University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,073 studies in Alcoholism with a site in United States — 187 open to participants now, 228 under way, 15 of them phase 3. Alcoholism · United States.

Enrollment
430th of 989
94 · median 80
Started
2017
with 40 others
No phase
436 of 1,073
85 open now
Registered
581st of 1,073
by date

Among the 1,073 studies in Alcoholism with a site in United States, this one is the 430th largest by enrollment of the 989 interventional ones that give a count, is one of 41 that started in 2017, is one of 436 with no phase, and was the 581st registered.

Alcoholism

1,676 studies on the registry are indexed under Alcoholism; 331 are open to participants now.

Browse Alcoholism studies →

Open to participants now

187 of the 1,073 studies in Alcoholism with a site in United States are open now. Recruiting first, the newest first:

182 more — sign in →

All 187 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 237 Alcoholism studies recruiting now, 84 (35%) set no upper age limit and 131 (55%) stop at 75 or younger; 9 take children under 18; 64 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,073 studies in Alcoholism with a site in United States, or all of them as a file.
02

Study 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). 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.

03

Conditions studied

  • Alcohol Dependence
  • Alcohol-Related Disorders
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. provide written
  2. be 18-65 years old
  3. meet criteria for moderate or severe alcohol use disorder
  4. express a desire to quit or cut down on their drinking.

Exclusion criteria

Exclusion Criteria:

Individuals who are:

  1. pregnant or lactating
  2. meet criteria for any other moderate or severe substance use disorders (excluding caffeine, nicotine, and marijuana),
  3. score 23 or greater on the Alcohol Withdrawal Symptom Checklist (a score indicating that medication would be likely required to manage alcohol detoxification)
  4. use prescribed or over-the-counter medicines containing alcohol
  5. participated in any previous studies that included EFT at the Addiction Recovery Research Center in the last three months
  6. have immediate plans to move out of the area
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
94 participants (actual)

Study arms

  • 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.

    Behavioral: Episodic Future Thinking (EFT)

  • 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.

    Behavioral: Episodic Recent Thinking (ERT)

Interventions

  • BehavioralEpisodic 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.

  • BehavioralEpisodic 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.

06

What researchers measure

Primary outcomes

  1. Change in average daily alcohol consumption

    Change in average daily alcohol consumption collected using self reports

    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).

Secondary outcomes

  1. Change in delay discounting rate

    Discounting rates will be measured using adjusting amount delay discounting and minute delay discounting tasks

    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

  2. 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)

    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

  3. 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)

    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

07

Study locations

1 site
  • Fralin Biomedical Research Institute at VTC
    Roanoke, Virginia 24016, United States
08

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Sep 2019, 23 months.

Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 54. This study's 23 months is below that.

Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2017
First posted
Nov 13, 2017
StartActual
Sep 21, 2017
Primary completionActual
Sep 17, 2019
CompletionActual
Oct 3, 2019
Last update
Feb 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03340051
Responsible party
Stephen LaConte (Professor, Virginia Polytechnic Institute and State University) — Principal investigator
First posted
Nov 13, 2017
Start date
Sep 21, 2017
Primary completion
Sep 17, 2019
Completion
Oct 3, 2019
Last update
Feb 12, 2025

Study contacts

Warren K Bickel, PhD
principal investigator · Virginia Tech Carilion School of Medicine and Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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