Adults 21 to 65, any sex, with Alcohol Drinking or Alcohol Drinking Related Problems. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Self-reported Alcohol Craving in the Laboratory SessionsPrimary· Up to 75 minutes during trial 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 reinstate
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
33.7
19.4 – 48.2
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
16.1
1.7 – 30.5
Self-reported Alcohol Craving in the Laboratory Sessions - Reinstatement TrialPrimary· Up to 90 minutes during reinstatement trials in a single day visit
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 b
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
24.7
17.7 – 34.1
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
9.7
5.7 – 16.4
Drinking in Daily Life Assessed With the Ecological Momentary Assessment (EMA)Primary· 22-37 days
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.
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
0.549
0.353 – 0.729
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
0.513
0.285 – 0.733
Craving in Daily Life Assessed With Event-contingent Ecological Momentary Assessment (EMA)Primary· 22-37 days
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
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
7.1
1.6 – 22.7
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
13.8
3.5 – 40.2
Craving in Daily Life Assessed With Random-prompt Ecological Momentary Assessment (EMA)Primary· 22-37 days
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.
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
28.1
10.2 – 55.7
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
7.2
1.4 – 23.2
Change in Alcohol Craving Assessed Using the Penn Alcohol Craving ScaleSecondary· Day 1 of study and 30 days after the final laboratory session
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
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
0.4
-3.1 – 3.9
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
1.6
-2.6 – 5.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 3 months from start of study.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA)
Last refreshed: 16 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02831049.