Effects of a New Behavioral Intervention on Alcohol Craving and Drinking

NCT02831049 | Completed Results

• 2 other identifiers: 99991614016-DA-N140
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Alcohol Drinking Related Problems

Keywords

Reconsolidation

Outcome Measures

Primary Outcomes (5)

• 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).

  Up to 75 minutes during trial sessions

• 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).

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

• 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.

  22-37 days

• 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

  22-37 days

• 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.

  22-37 days

Secondary Outcomes (1)

• Change in Alcohol Craving Assessed Using the Penn Alcohol Craving Scale

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

Study Arms (3)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

Retrieval-extinction BEHAVIORAL

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

Control Group A: Soft-drink retrieval / Alcohol extinction (S/A); Control Group B: Alcohol retrieval / Soft-drink extinction (A/S); Experimental Group: Alcohol retrieval / Alcohol extinction (A/A)

Alcohol-related cues BEHAVIORAL

Alcohol related cues

Control Group A: Soft-drink retrieval / Alcohol extinction (S/A); Experimental Group: Alcohol retrieval / Alcohol extinction (A/A)

Soft-drink related cues BEHAVIORAL

Soft drink related cues

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

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Dr David Epstein
• Organization: National Institute on Drug Abuse (NIDA)

david.epstein@nih.gov

1-667-312-5092

Study Officials

• David H Epstein, M.D, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2016
• First Posted: July 13, 2016
• Study Start: May 5, 2017
• Primary Completion: April 21, 2020
• Study Completion: April 21, 2020
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2024-10-09

Data Sharing

• IPD Sharing: Will share
• Access Criteria: We will share some protocol data with our scientific research partners inside or outside the NIH. Research partners outside the NIH sign an agreement with the NIH to share data. This agreement indicates the type of data that can be shared and what can be done with those data.

Locations

US (1)