Clinical trial NCT02831049: Effects of a New Behavioral Intervention on Alcohol Craving and Drinking
Official title: Effects of a New Behavioral Intervention on Alcohol Craving and Drinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Alcohol Drinking Related Problems
Keywords: Reconsolidation
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2016-07-13
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Change in Self-reported Alcohol Craving in the Laboratory Sessions
timeFrame: Up to 75 minutes during trial sessions
measure: Self-reported Alcohol Craving in the Laboratory Sessions - Reinstatement Trial
timeFrame: Up to 90 minutes during reinstatement trials in a single day visit
measure: Drinking in Daily Life Assessed With the Ecological Momentary Assessment (EMA)
timeFrame: 22-37 days
measure: Craving in Daily Life Assessed With Event-contingent Ecological Momentary Assessment (EMA)
timeFrame: 22-37 days
measure: Craving in Daily Life Assessed With Random-prompt Ecological Momentary Assessment (EMA)
timeFrame: 22-37 days
Secondary outcomes:
measure: Change in Alcohol Craving Assessed Using the Penn Alcohol Craving Scale
timeFrame: Day 1 of study and 30 days after the final laboratory session
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: National Institute on Drug Abuse
state: Maryland
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: David H Epstein, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: