CClinicalTrials.gg
Sign In
CompletedNCT02831049Updated Jan 16, 2025Results posted

Effects of a New Behavioral Intervention on Alcohol Craving and Drinking

An interventional study of Retrieval-extinction and Alcohol-related cues in Alcohol Drinking and Alcohol Drinking Related Problems, sponsored by National Institute on Drug Abuse (NIDA). Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-16.

Sponsored by National Institute on Drug Abuse (NIDA) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study summary

Background:

Sights, sounds, and smells can be associated with alcohol and tempt people to drink. The connection between encountering cues and wanting to drink might be reduced by behavioral techniques, like giving the cues at certain times, in certain circumstances.

Objective:

To see if visual imagery and behavioral techniques can reduce alcohol craving and drinking.

Eligibility:

Healthy people ages 21 to 65 years old who are mildly concerned about their drinking and have had these habits in the past 3 months:

  • Women: More than three (3) drinks any single day or more than seven (7) drinks per week
  • Men: More than four (4) drinks any single day or more than 14 drinks per week

Design:

  • Participants will be screened with medical history, physical exam, blood tests, alcohol breath tests, hepatitis tests, and alcohol and drug use questionnaires.
  • Participants will get a smartphone to carry throughout the study. They will use it to report on their drinking, moods, and activities daily. The phone's global positioning system (GPS) will record their locations throughout each day.

  • There will be six (6) study visits approximately over four (4) weeks. Visits will last up to four (4) hours, but the final visit may last up to seven (7) hours. Visits include the following:

    • Not drinking alcohol or using illicit or over-the-counter drugs at least 24 hours before each visit
    • Providing urine and breath samples.
    • Exposure to various cues: Participants' reactions will be monitored by measuring heart rate, blood pressure, and skin temperature.
    • Drinking alcohol or soft drinks: For visits with alcohol, transportation to and from the visit will be provided.
  • About a month after the last visit, participants will be called to ask about their drinking and cravings.
Read the detailed description

Objective: To evaluate alcohol memory retrieval-extinction, a novel behavioral procedure for reduction of craving and drinking, in problem drinkers.

Study population: We will collect evaluable data from up to 75 participants. Participants are evaluable if they complete ecological momentary assessment (EMA, described below). All participants will be adult alcohol drinkers (men: > 14 drinks/week or > 4 drinks/day; women: > 7 drinks/week or > 3 drinks/day) whose drinking scores as hazardous on the Alcohol Use Disorders Identification Test. Participants will not be seeking treatment for an alcohol-use disorder, be physiologically dependent on alcohol, or have other drug use disorders. Participants can have nicotine use disorder.

Design: A randomized study with three groups. Participants will use smartphones to provide geotagged reports of alcohol craving and drinking in daily life (EMA reports) before, between, and after a series of laboratory sessions. During sessions, participants will drink an alcoholic beverage (individualized to produce a 0.06 g/dL blood alcohol content) or a soft drink. Participants will then be repeatedly presented with alcohol or soft drink-associated cues without further drinking. These are the memory retrieval and extinction portions, respectively, of memory retrieval-extinction. Previous studies suggest this procedure can robustly reduce Pavlovian associations between cues and responses such as craving. The mechanism seems to involve memory reconsolidation, in which freshly retrieved associations (e.g. drink cues and consumption - pleasant effects) become more vulnerable to disruption by extinction.

Three groups will be tested: (1) alcohol retrieval / alcohol extinction will be compared to (2) soft-drink retrieval / alcohol extinction and (3) alcohol retrieval / soft-drink extinction. Before and after retrieval-extinction, participants will be tested for alcohol craving and cue-induced physiological responses in laboratory sessions. Retrieval-extinction will be followed by approximately one week of follow-up EMA reporting, with telephone contact approximately 30 days thereafter.

Outcome parameters:

  • The co-primary outcome measures are: self-reported alcohol craving in the laboratory sessions before and after retrieval-extinction, and EMA reports of alcohol craving and drinking. Daily-life responses are important because the version of retrieval-extinction we will be using, with retrieval induced by drinking alcohol itself, rather than alcohol cues alone, may be especially likely to have effects that generalize from the laboratory to daily life.
  • Secondary outcome measures are: self-reported alcohol craving and drinking at 30-day follow-up
02

Conditions studied

  • Alcohol Drinking
  • Alcohol Drinking Related Problems

Browse trials for

Keywords

  • Reconsolidation
03

In context

Alcohol Drinking

925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.

This study's enrollment of 23 is below the median of 108 across 802 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 21 and 65 years inclusive

  • Drinking at high levels for at least 10 different weeks during the last 90 days. High-level drinking for a given week can be either of the following:

    • For women, more than 3 drinks on any single day that week, or more than 7 drinks that week
    • For men, more than 4 drinks on any single day that week, or more than 14 drinks that week
  • A score greater than or equal to 8 and less than or equal to 15 on the self-report version of the Alcohol Use Disorders Identification Test (AUDIT), with endorsement of at least one item other than 1-3, because 1-3 assess only consumption, not concern or consequences
  • Self-report of liking or having neutral feelings about the sight and smell of alcoholic beverages

  • For women,

    • practicing an effective method of birth control before entry and throughout the study (or postmenopausal for at least one year, or surgically sterile)
    • negative urine pregnancy test at each visit.
    • Effective methods of birth control are those approved by the Food and Drug Administration (FDA) used as described in the FDA Birth Control Guide These methods are: (1) intrauterine device (IUD) copper; (2) IUD with progestin; (3) implantable rod; (4) contraceptive shot/injection; (5) oral contraceptives (combined pill, progestin-only pill, or extended/continuous-use combined pill); (6) contraceptive patch; (7) vaginal contraceptive ring; (8) diaphragm with spermicide; (9) sponge with spermicide; (10) cervical cap with spermicide; (11) male condom; (12) female condom; (13) male partner with a vasectomy. Abstinence from sexual intercourse is also an effective method of birth control.

Exclusion criteria

EXCLUSION CRITERIA:

  • Risk of alcohol withdrawal, as determined by any of the following:

    • a score less than 8 or greater than 15 on the Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar) following a negative breath test for alcohol (i.e., blood alcohol concentration of 0.0)
    • lifetime history of delirium tremens or seizures (related to alcohol or not),
    • endorsement of a drinking to avoid withdrawal symptom on the Structured Clinical Interview for Diagnostic and Statistical Manual Disorders (SCID) or Mini International Neuropsychiatric Interview (M.I.N.I) (M.I.N.I. Section I, Alcohol Use Disorder, items k1 and/or k2 answered affirmatively with counselor's evaluation to verify that symptoms indicated in item k1 are related to the individual's cutting down on drinking and/or the response to item k2 refers to withdrawal symptoms and not hangover);
    • OR physician's judgment.
  • Currently trying to quit drinking, or planning to quit or reduce alcohol drinking via formal treatment or support-group attendance in the next six months;
  • For women: pregnancy, breastfeeding, or planning to become pregnant during the experiment
  • Current liver disease or dysfunction, assessed by physical examination and medical history; and hepatitis C, chronic hepatitis B, or other current liver disease or dysfunction as assessed by physical examination and medical history or as reflected in blood levels more than 5 times the upper limit of normal in any of the following: aspartate transaminase (AST), alanine transaminase (ALT), or gamma-glutamyltransferase (GGT)
  • Any other medical illness or condition that in the judgment of the investigators is incompatible with alcohol consumption
  • Current use of prescription or over-the-counter medications or herbal products for which drinking alcohol is strictly prohibited. When the metabolic half-life of the medication/product is known, we will require at least 7 half-lives to have elapsed before any session involving alcohol consumption. If the half-life is not known (as might be the case for some herbal preparations), we will require at least 7 days to have elapsed since the last use before any session involving alcohol consumption
  • Substance-use disorder for any drug(s) other than alcohol or nicotine in the previous 12 months
  • Past or present diagnosis of bipolar disorder or any psychotic disorder; any history of suicide attempt or current suicidal ideation; present diagnosis of uncontrolled or untreated mood or anxiety disorder
  • Cognitive impairment severe enough to preclude informed consent or valid self-report
05

Study design

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

Study arms

  • Experimental
    Experimental Group: Alcohol retrieval / Alcohol extinction (A/A)

    Participant drinks an alcoholic beverage (individualized to produce a 0.06 g/dL blood alcohol content). Participant is then repeatedly presented with alcohol-associated cues without further drinking. Participant completes four sessions of memory retrieval and extinction portions, a novel behavioral procedure for reduction of craving and drinking, in problem drinkers.

    Behavioral: Retrieval-extinction · Behavioral: Alcohol-related cues

  • Active comparator
    Control Group A: Soft-drink retrieval / Alcohol extinction (S/A)

    Participant undergoes retrieval with with soft drink cues followed by extinction with alcohol-related cues without further drinking. Participant completes four sessions of memory retrieval and extinction portions, a novel behavioral procedure for reduction of craving and drinking, in problem drinkers.

    Behavioral: Retrieval-extinction · Behavioral: Alcohol-related cues

  • Active comparator
    Control Group B: Alcohol retrieval / Soft-drink extinction (A/S)

    Participant drinks an alcoholic beverage (individualized to produce a 0.06 g/dL blood alcohol content). Participant is then repeatedly presented with soft drink-associated cues without further drinking. Participant completes four sessions of memory retrieval and extinction portions, a novel behavioral procedure for reduction of craving and drinking, in problem drinkers.

    Behavioral: Retrieval-extinction · Behavioral: Soft-drink related cues

Interventions

  • BehavioralRetrieval-extinction

    Memory retrieval-extinction is a novel behavioral procedure for reduction of craving and drinking in problem drinkers.

  • BehavioralAlcohol-related cues

    Alcohol related cues

  • BehavioralSoft-drink related cues

    Soft drink related cues

06

What researchers measure

Primary outcomes

  1. Change in Self-reported Alcohol Craving in the Laboratory Sessions

    Participants were presented with alcohol cues and an alcohol-containing beverage in the laboratory sessions then cue-elicited craving was measured on a visual analogue scale using the question, "How much do want a drink right now?" on a scale of 0 = "I don't want a drink at all," to 100 = "I really want a drink". Higher score indicates more alcohol craving. The procedure was done in four intervention sessions, called retrieval-extinction sessions, and then in a test session as follows: Tests of renewal (control context was extinction context; challenge context was novel context) and reinstatement (by a priming dose of alcohol) were used to assess the success of the retrieval-extinction intervention. The outcome measure in the final session was changes in craving before versus after renewal, and again after reinstatement. Results are expressed as the estimated mean change in scores (after cues minus before cues).

    Time frame: Up to 75 minutes during trial sessions

  2. Self-reported Alcohol Craving in the Laboratory Sessions - Reinstatement Trial

    Participants were presented with soft drink to drink, then craving was measured. Next participants were presented with alcohol to drink followed by craving measurement. Cue-elicited craving was measured on a visual analogue scale using the question, "How much do want a drink right now?" on a scale of 0 = "I don't want a drink at all," to 100 = "I really want a drink". Higher score indicates more alcohol craving. This outcome used a reinstatement procedure in which, instead of alcohol-related cues, the unconditioned stimulus (alcohol) is presented (participants are provided with an alcoholic beverage), to determine whether the extinguished response (craving) reappears (a "priming" effect). Results are expressed as the estimated mean change scores (after cues minus before cues).

    Time frame: Up to 90 minutes during reinstatement trials in a single day visit

  3. Drinking in Daily Life Assessed With the Ecological Momentary Assessment (EMA)

    Participants drinking over the course of the study was assessed through ecological momentary assessment (EMA), based on self-reports provided through random-prompt and event-contingent entries. Participants reported drinking or not report drinking on each day. EMA uses real-time assessments of behavior and emotion on mobile electronic devices. Results are expressed as the estimated probability of reporting drinking within a day.

    Time frame: 22-37 days

  4. Craving in Daily Life Assessed With Event-contingent Ecological Momentary Assessment (EMA)

    Participants craving over the course of the study was assessed through ecological momentary assessment (EMA), based on self-reports provided through event-contingent entries initiated by the participant whenever they feel a craving, urge, or temptation to drink, in response to the question on a visual analogue scale, "How much do want a drink right now?" on a scale of 0 = "I don't want a drink at all," to 100 = "I really want a drink". Higher score indicates more alcohol craving. Results are expressed as the estimated mean of level of craving

    Time frame: 22-37 days

  5. Craving in Daily Life Assessed With Random-prompt Ecological Momentary Assessment (EMA)

    Participant craving over the course of the study was assessed through ecological momentary assessment , based on self-reports provided through random-prompt entries in response to the question on a visual analogue scale, "How much do want a drink right now?" on a scale of 0 = "I don't want a drink at all," to 100 = "I really want a drink". Higher score indicates more alcohol craving. Results are expressed as the estimated mean of level of craving.

    Time frame: 22-37 days

Secondary outcomes

  1. Change in Alcohol Craving Assessed Using the Penn Alcohol Craving Scale

    Penn Alcohol Craving Scale (PACS) is a self-reported measure that inquires about the frequency, intensity, and duration of craving, the ability to resist drinking, and overall rating of craving for alcohol on a week's timescale, providing a retrospective measure of craving. PACS is a five item questionnaire with each item scored from 0 to 6. Total score range from 0 to 30. Higher score indicates more frequent craving. Craving was measured in once on the first day of treatment and again in a phone call 30 days after last laboratory session. Outcome was analyzed as the change in score (day 30 score minus day 1 score).

    Time frame: Day 1 of study and 30 days after the final laboratory session

07

Results

Posted Jan 16, 2025

Participant flow

Participant flow — Overall Study
MilestoneExperimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
Started788
Completed676
Not completed112
Withdrew: Lost to follow-up001
Withdrew: Withdrawal by subject011
Withdrew: Pandemic shutdown100

Outcome measures

PrimaryChange in Self-reported Alcohol Craving in the Laboratory Sessions

Participants were presented with alcohol cues and an alcohol-containing beverage in the laboratory sessions then cue-elicited craving was measured on a visual analogue scale using the question, "How much do want a drink right now?" on a scale of 0 = "I don't want a drink at all," to 100 = "I really want a drink". Higher score indicates more alcohol craving. The procedure was done in four intervention sessions, called retrieval-extinction sessions, and then in a test session as follows: Tests of renewal (control context was extinction context; challenge context was novel context) and reinstatement (by a priming dose of alcohol) were used to assess the success of the retrieval-extinction intervention. The outcome measure in the final session was changes in craving before versus after renewal, and again after reinstatement. Results are expressed as the estimated mean change in scores (after cues minus before cues).

Time frame:
Up to 75 minutes during trial sessions
Reported as:
Mean · units on a scale
Change in Self-reported Alcohol Craving in the Laboratory Sessions
units on a scaleExperimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
Extinction context11.7 (-1.3 to 24.0)20.1 (6.9 to 33.0)15.3 (1.1 to 29.1)
Novel context10.0 (-3.4 to 23.4)33.7 (19.4 to 48.2)16.1 (1.7 to 30.5)
PrimarySelf-reported Alcohol Craving in the Laboratory Sessions - Reinstatement Trial

Participants were presented with soft drink to drink, then craving was measured. Next participants were presented with alcohol to drink followed by craving measurement. Cue-elicited craving was measured on a visual analogue scale using the question, "How much do want a drink right now?" on a scale of 0 = "I don't want a drink at all," to 100 = "I really want a drink". Higher score indicates more alcohol craving. This outcome used a reinstatement procedure in which, instead of alcohol-related cues, the unconditioned stimulus (alcohol) is presented (participants are provided with an alcoholic beverage), to determine whether the extinguished response (craving) reappears (a "priming" effect). Results are expressed as the estimated mean change scores (after cues minus before cues).

Time frame:
Up to 90 minutes during reinstatement trials in a single day visit
Reported as:
Mean · units on a scale
Self-reported Alcohol Craving in the Laboratory Sessions - Reinstatement Trial
units on a scaleExperimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
Self-reported Alcohol Craving in the Laboratory Sessions - Reinstatement Trial18.7 (11.6 to 28.3)24.7 (17.7 to 34.1)9.7 (5.7 to 16.4)
PrimaryDrinking in Daily Life Assessed With the Ecological Momentary Assessment (EMA)

Participants drinking over the course of the study was assessed through ecological momentary assessment (EMA), based on self-reports provided through random-prompt and event-contingent entries. Participants reported drinking or not report drinking on each day. EMA uses real-time assessments of behavior and emotion on mobile electronic devices. Results are expressed as the estimated probability of reporting drinking within a day.

Time frame:
22-37 days
Reported as:
Mean · Probability of reported drinking/day
Drinking in Daily Life Assessed With the Ecological Momentary Assessment (EMA)
Probability of reported drinking/dayExperimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
Drinking in Daily Life Assessed With the Ecological Momentary Assessment (EMA)0.799 (0.616 to 0.906)0.549 (0.353 to 0.729)0.513 (0.285 to 0.733)
PrimaryCraving in Daily Life Assessed With Event-contingent Ecological Momentary Assessment (EMA)

Participants craving over the course of the study was assessed through ecological momentary assessment (EMA), based on self-reports provided through event-contingent entries initiated by the participant whenever they feel a craving, urge, or temptation to drink, in response to the question on a visual analogue scale, "How much do want a drink right now?" on a scale of 0 = "I don't want a drink at all," to 100 = "I really want a drink". Higher score indicates more alcohol craving. Results are expressed as the estimated mean of level of craving

Time frame:
22-37 days
Reported as:
Mean · units on a scale
Craving in Daily Life Assessed With Event-contingent Ecological Momentary Assessment (EMA)
units on a scaleExperimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
Craving in Daily Life Assessed With Event-contingent Ecological Momentary Assessment (EMA)5.5 (0.8 to 20.6)7.1 (1.6 to 22.7)13.8 (3.5 to 40.2)
PrimaryCraving in Daily Life Assessed With Random-prompt Ecological Momentary Assessment (EMA)

Participant craving over the course of the study was assessed through ecological momentary assessment , based on self-reports provided through random-prompt entries in response to the question on a visual analogue scale, "How much do want a drink right now?" on a scale of 0 = "I don't want a drink at all," to 100 = "I really want a drink". Higher score indicates more alcohol craving. Results are expressed as the estimated mean of level of craving.

Time frame:
22-37 days
Reported as:
Mean · units on a scale
Craving in Daily Life Assessed With Random-prompt Ecological Momentary Assessment (EMA)
units on a scaleExperimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
Craving in Daily Life Assessed With Random-prompt Ecological Momentary Assessment (EMA)24.8 (7.8 to 55.0)28.1 (10.2 to 55.7)7.2 (1.4 to 23.2)
SecondaryChange in Alcohol Craving Assessed Using the Penn Alcohol Craving Scale

Penn Alcohol Craving Scale (PACS) is a self-reported measure that inquires about the frequency, intensity, and duration of craving, the ability to resist drinking, and overall rating of craving for alcohol on a week's timescale, providing a retrospective measure of craving. PACS is a five item questionnaire with each item scored from 0 to 6. Total score range from 0 to 30. Higher score indicates more frequent craving. Craving was measured in once on the first day of treatment and again in a phone call 30 days after last laboratory session. Outcome was analyzed as the change in score (day 30 score minus day 1 score).

Time frame:
Day 1 of study and 30 days after the final laboratory session
Reported as:
Mean · units on a scale
Change in Alcohol Craving Assessed Using the Penn Alcohol Craving Scale
units on a scaleExperimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
Change in Alcohol Craving Assessed Using the Penn Alcohol Craving Scale-0.3 (-4.1 to 3.5)0.4 (-3.1 to 3.9)1.6 (-2.6 to 5.7)

Adverse events

Collected over Up to 3 months from start of study. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)0/7 (0%)0/7 (0%)1/7 (14.3%)
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)0/8 (0%)0/8 (0%)1/8 (12.5%)
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)0/8 (0%)0/8 (0%)0/8 (0%)
Most frequent other events
Most frequent other events
EventExperimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
Menstrual discomfortReproductive system and breast disorders1/70/80/8
DiarrhoeaGastrointestinal disorders0/71/80/8

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)Total
<=18 years0000
Between 18 and 65 years78823
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)Total
Female3339
Male45514
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)Total
Hispanic or Latino1012
Not Hispanic or Latino68721
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)Total
American Indian or Alaska Native0000
Asian1001
Native Hawaiian or Other Pacific Islander0000
Black or African American0448
White62412
More than one race0202
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)Total
United States78823
08

Study locations

1 site
  • National Institute on Drug Abuse
    Baltimore, Maryland 21224, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 16, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Some health information collected may be placed into one or more scientific databases after it has been stripped of identifiers such as name, address or account number, so that it may be used for future research on any topic and shared broadly for research purposes. A researcher who wants to study the information must apply to the database and be approved.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02831049
Lead sponsor
National Institute on Drug Abuse (NIDA)
Responsible party
Sponsor
First posted
Jul 13, 2016
Start date
May 5, 2017
Primary completion
Apr 21, 2020
Completion
Apr 21, 2020
Results posted
Jan 16, 2025
Last update
Jan 16, 2025

Study contacts

David H Epstein, M.D, Ph.D.
principal investigator · National Institute on Drug Abuse (NIDA)

Oversight

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 Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Alcohol Drinking→

Other studies from this sponsor

National Institute on Drug Abuse (NIDA)

Start the discussion