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Remote Alcohol Monitoring and Episodic Thinking (RMET)

Primary Purpose

Alcohol Dependence, Alcohol-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Episodic Future Thinking (EFT)
Episodic Recent Thinking (ERT)
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Individuals who are:

  1. pregnant or lactating
  2. meet DSM-V 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

Sites / Locations

  • Fralin Biomedical Research Institute at VTC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

EFT group

ERT group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in average daily alcohol consumption
Change in average daily alcohol consumption collected using self reports

Secondary Outcome Measures

Change in delay discounting rate
Discounting rates will be measured using adjusting amount delay discounting and minute delay discounting tasks
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)
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)

Full Information

First Posted
November 3, 2017
Last Updated
October 12, 2021
Sponsor
Virginia Polytechnic Institute and State University
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1. Study Identification

Unique Protocol Identification Number
NCT03340051
Brief Title
Remote Alcohol Monitoring and Episodic Thinking
Acronym
RMET
Official Title
Episodic Thinking (ET) as a Candidate Technique to Reduce Alcohol Consumption
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
September 17, 2019 (Actual)
Study Completion Date
October 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Polytechnic Institute and State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Alcohol-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EFT group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ERT group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Episodic Future Thinking (EFT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Episodic Recent Thinking (ERT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in average daily alcohol consumption
Description
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 Outcome Measure Information:
Title
Change in delay discounting rate
Description
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
Title
Change in intensity of alcohol demand
Description
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
Title
Change in elasticity of alcohol demand
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren K Bickel, PhD
Organizational Affiliation
Virginia Tech Carilion School of Medicine and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fralin Biomedical Research Institute at VTC
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35041442
Citation
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.
Results Reference
derived

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Remote Alcohol Monitoring and Episodic Thinking

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