Effects of a New Behavioral Intervention on Alcohol Craving and Drinking

Not Applicable

Completed

Conditions: Alcohol Drinking
Alcohol Drinking Related Problems

Interventions: Behavioral: Extinction
Behavioral: Retrieval
Behavioral: Retrieval-extinction

Registration Number: NCT02831049

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief 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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Extinction	soft-drink retrieval / alcohol extinction
3	Retrieval	alcohol retrieval / soft-drink extinction
1	Retrieval-extinction	alcohol retrieval / alcohol extinction

Primary Outcome Measures

Name	Time	Method
Change in Self-reported Alcohol Craving in the Laboratory Sessions	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 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).
Self-reported Alcohol Craving in the Laboratory Sessions - Reinstatement Trial	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 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).
Drinking in Daily Life Assessed With the Ecological Momentary Assessment (EMA)	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.
Craving in Daily Life Assessed With Event-contingent Ecological Momentary Assessment (EMA)	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
Craving in Daily Life Assessed With Random-prompt Ecological Momentary Assessment (EMA)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Alcohol Craving Assessed Using the Penn Alcohol Craving Scale	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 score minus day 1 score).