Effects of a New Behavioral Intervention on Alcohol Craving and Drinking
Effects of a New Behavioral Intervention on Alcohol Craving and Drinking
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 65 who are mildly concerned about their drinking and have had these
 habits in the past 3 months:

 Women: More than 3 drinks any single day and more than 7 drinks per week

 Men: More than 4 drinks any single day and 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 GPS will record their locations
 throughout each day.

 There will be 6 study visits over 4 weeks. Visits will last up to 4 hours, but the final
 visit lasts up to 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.
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 geographical momentary assessment (GMA, 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.

 Design: A randomized study with three groups. Participants will use smartphones to provide
 geotagged reports of alcohol craving and drinking in daily life (GMA 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 1 week of follow-up GMA reporting, with telephone contact 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 GMA 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: (1) self-reported alcohol craving and drinking at
 30-day follow-up, (2) physiological reactivity during sessions, and (3) urine biomarkers for
 alcohol consumption.
-  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 greater than or
 equal to 8 on the Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar)
 following a negative breath test for alcohol (i.e., BAC 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 SCID or 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