Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03340051 |
Other study ID # |
RMET/15-955 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 21, 2017 |
Est. completion date |
October 3, 2019 |
Study information
Verified date |
October 2021 |
Source |
Virginia Polytechnic Institute and State University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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). 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.
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.