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D-Cycloserine to Enhance Extinction to Alcohol Cues

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ClinicalTrials.gov Identifier: NCT01362309
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : February 19, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
There is considerable evidence that Alcohol Use Disorders (AUDs) can be understood as a form of dysregulated learning and are influenced by classical conditioning. This is based on numerous studies indicating that conditioned contextual cues influence craving for alcohol consumption. As a result, there has been considerable interest in extinction-based treatments for AUDs (i.e., treatments that focus on extinguishing the associations between alcohol cues and motivation to drink), referred to as cue exposure treatment To date, extinction-based treatment for AUDs has resulted in disappointing outcomes in clinical trials and there is considerable interest in improving this form of treatment. One novel strategy is the use of pharmacological adjuncts to enhance extinction. Medications that maximize extinction may minimize subsequent reactions to alcohol cues and, in turn, subsequent clinical outcomes. This study is examining whether the medication d-cycloserine (DCS) can enhance extinction to alcohol cues. Recent basic research has revealed that DCS enhances extinction to fear cues and several lines of evidence suggest that DCS may also enhance extinction to alcohol cues. Therefore, DCS may serve as a useful pharmacological adjunct to extinction-based treatment for AUDs. Our primary aim is to examine whether, compared to placebo, DCS (50 mg) will enhance extinction to alcohol cues under controlled laboratory conditions in treatment-seeking individuals with alcohol use disorders. We hypothesize that DCS will generate greater extinction compared to placebo during the subsequent extinction session as measured by attenuated craving in response to alcohol cues. Furthermore, we hypothesize that DCS will generate greater extinction compared to placebo at follow-up assessments. This study is a proof-of-concept test of whether DCS can reduce reactions to alcohol cues under controlled laboratory conditions. It is a preliminary study using a subclinical number of extinction sessions and medication administrations to establish whether or not DCS improves extinction in the laboratory. If proof-of-concept is supported, it will suggest that a clinical trial is warranted. A clinical sample and clinical context are used to maximize the potential generalizability from this exploratory study.

Condition or disease Intervention/treatment
Alcohol Use Disorders. Drug: d-cycloserine.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: D-Cycloserine to Enhance Extinction to Alcohol Cues
Study Start Date : November 2010
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
Inert filler in matched pill.
Drug: d-cycloserine.
50 mg administered on two occasions.
Other Name: Seromycin.
Active Comparator: d-cycloserine 50 mg
50 mg d-cycloserine.
Drug: d-cycloserine.
50 mg administered on two occasions.
Other Name: Seromycin.

Outcome Measures

Primary Outcome Measures :
  1. Change in Craving for alcohol. [ Time Frame: Laboratory sessions (two, one-week apart): change in craving over 11 occasions, 5 minutes apart. Between sessions: change in craving across 7 occasions (Study Day: 1, 4, 7, 12, 19, 33, 40). ]
    Subjective desire for alcohol is assessed intermittently during extended exposure to alcohol cues with response prevention within laboratory sessions and over the preceding week at 6 study visits.

Secondary Outcome Measures :
  1. Change in Tolerability [ Time Frame: Prevalence and change in side effects measured on 4 occasions (Study Day: 1, 4, 7, 12) ]
    Side effects resulting from d-cycloserine in individuals with alcohol use disorders.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Presence of an alcohol use disorder.
  2. At least 14+/7+ drinks/week for males/females.
  3. Alcohol cue reactivity.
  4. 9th grade education or greater.
  5. 21-65 years old.
  6. Stable contact information.
  7. Treatment-seeking.

Exclusion Criteria:

  1. Participation in a previous study of d-cycloserine.
  2. Mandated to treatment.
  3. Significant withdrawal symptoms (i.e., Clinical Institute Withdrawal Scale - Revised score of 15+, history of previous withdrawal-related hospitalizations, or withdrawal-related hallucinations).
  4. Current DSM IV Axis I conditions other than alcohol and nicotine dependence.
  5. Living with a previous study participant.
  6. No medical contraindications for d-cycloserine (i.e., currently taking ethionamide, isoniazid, SSRIs, history of epilepsy, history of hypersensitivity to DCS, or additional medical conditions deemed a risk at the physical exam by a study physician).
  7. Cardiovascular disease or uncontrolled hypertension (such conditions may contribute to abnormal psychophysiological arousal data), as determined by the study physician.
  8. Pregnant or seeking to conceive (females only).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362309

United States, Georgia
Experimental and Clinical Psychopharmacology Laboratory, Dept. of Psychology, University of Georgia
Athens, Georgia, United States, 30605
Sponsors and Collaborators
University of Georgia
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Boston University
Brown University
Principal Investigator: James MacKillop, PhD University of Georgia
More Information

Responsible Party: University of Georgia
ClinicalTrials.gov Identifier: NCT01362309     History of Changes
Other Study ID Numbers: R21AA017696 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: May 2011

Keywords provided by University of Georgia:

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Infective Agents, Urinary
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action