Trial Outcomes & Findings for Effects of a New Behavioral Intervention on Alcohol Craving and Drinking (NCT NCT02831049)
NCT ID: NCT02831049
Last Updated: 2025-01-16
Results Overview
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).
COMPLETED
NA
23 participants
Up to 75 minutes during trial sessions
2025-01-16
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
8
|
|
Overall Study
COMPLETED
|
6
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Pandemic shutdown
|
1
|
0
|
0
|
Baseline Characteristics
Effects of a New Behavioral Intervention on Alcohol Craving and Drinking
Baseline characteristics by cohort
| Measure |
Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)
n=7 Participants
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.
|
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
n=8 Participants
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.
|
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
n=8 Participants
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.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
23 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 75 minutes during trial sessionsPopulation: All participants who completed the study
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).
Outcome measures
| Measure |
Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)
n=6 Participants
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.
|
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
n=7 Participants
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.
|
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
n=6 Participants
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.
|
|---|---|---|---|
|
Change in Self-reported Alcohol Craving in the Laboratory Sessions
Extinction context
|
11.7 units on a scale
Interval -1.3 to 24.0
|
20.1 units on a scale
Interval 6.9 to 33.0
|
15.3 units on a scale
Interval 1.1 to 29.1
|
|
Change in Self-reported Alcohol Craving in the Laboratory Sessions
Novel context
|
10.0 units on a scale
Interval -3.4 to 23.4
|
33.7 units on a scale
Interval 19.4 to 48.2
|
16.1 units on a scale
Interval 1.7 to 30.5
|
PRIMARY outcome
Timeframe: Up to 90 minutes during reinstatement trials in a single day visitPopulation: All participants who completed the study.
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).
Outcome measures
| Measure |
Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)
n=6 Participants
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.
|
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
n=7 Participants
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.
|
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
n=6 Participants
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.
|
|---|---|---|---|
|
Self-reported Alcohol Craving in the Laboratory Sessions - Reinstatement Trial
|
18.7 units on a scale
Interval 11.6 to 28.3
|
24.7 units on a scale
Interval 17.7 to 34.1
|
9.7 units on a scale
Interval 5.7 to 16.4
|
PRIMARY outcome
Timeframe: 22-37 daysPopulation: All participants who completed the study
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.
Outcome measures
| Measure |
Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)
n=6 Participants
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.
|
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
n=7 Participants
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.
|
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
n=6 Participants
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.
|
|---|---|---|---|
|
Drinking in Daily Life Assessed With the Ecological Momentary Assessment (EMA)
|
0.799 Probability of reported drinking/day
Interval 0.616 to 0.906
|
0.549 Probability of reported drinking/day
Interval 0.353 to 0.729
|
0.513 Probability of reported drinking/day
Interval 0.285 to 0.733
|
PRIMARY outcome
Timeframe: 22-37 daysPopulation: All participants who completed the study.
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
Outcome measures
| Measure |
Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)
n=6 Participants
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.
|
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
n=7 Participants
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.
|
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
n=6 Participants
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.
|
|---|---|---|---|
|
Craving in Daily Life Assessed With Event-contingent Ecological Momentary Assessment (EMA)
|
5.5 units on a scale
Interval 0.8 to 20.6
|
7.1 units on a scale
Interval 1.6 to 22.7
|
13.8 units on a scale
Interval 3.5 to 40.2
|
PRIMARY outcome
Timeframe: 22-37 daysPopulation: All participants who completed the study.
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.
Outcome measures
| Measure |
Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)
n=6 Participants
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.
|
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
n=7 Participants
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.
|
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
n=6 Participants
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.
|
|---|---|---|---|
|
Craving in Daily Life Assessed With Random-prompt Ecological Momentary Assessment (EMA)
|
24.8 units on a scale
Interval 7.8 to 55.0
|
28.1 units on a scale
Interval 10.2 to 55.7
|
7.2 units on a scale
Interval 1.4 to 23.2
|
SECONDARY outcome
Timeframe: Day 1 of study and 30 days after the final laboratory sessionPopulation: All participants who completed the study.
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).
Outcome measures
| Measure |
Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)
n=6 Participants
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.
|
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
n=7 Participants
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.
|
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
n=6 Participants
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.
|
|---|---|---|---|
|
Change in Alcohol Craving Assessed Using the Penn Alcohol Craving Scale
|
-0.3 units on a scale
Interval -4.1 to 3.5
|
0.4 units on a scale
Interval -3.1 to 3.9
|
1.6 units on a scale
Interval -2.6 to 5.7
|
Adverse Events
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)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Group: Alcohol Retrieval / Alcohol Extinction (A/A)
n=7 participants at risk
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.
|
Control Group A: Soft-drink Retrieval / Alcohol Extinction (S/A)
n=8 participants at risk
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.
|
Control Group B: Alcohol Retrieval / Soft-drink Extinction (A/S)
n=8 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • Up to 3 months from start of study
|
12.5%
1/8 • Up to 3 months from start of study
|
0.00%
0/8 • Up to 3 months from start of study
|
|
Reproductive system and breast disorders
Menstrual discomfort
|
14.3%
1/7 • Up to 3 months from start of study
|
0.00%
0/8 • Up to 3 months from start of study
|
0.00%
0/8 • Up to 3 months from start of study
|
Additional Information
Dr David Epstein
National Institute on Drug Abuse (NIDA)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place