D-Cycloserine to Enhance Extinction to Alcohol Cues

NCT ID: NCT01362309

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-10-31

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.

Conditions

Alcohol Use Disorders.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Inert filler in matched pill.

Group Type: PLACEBO_COMPARATOR

d-cycloserine.

Intervention Type: DRUG

50 mg administered on two occasions.

d-cycloserine 50 mg

50 mg d-cycloserine.

Group Type: ACTIVE_COMPARATOR

d-cycloserine.

Intervention Type: DRUG

50 mg administered on two occasions.

Interventions

d-cycloserine.

50 mg administered on two occasions.

Intervention Type: DRUG

Other Intervention Names

Seromycin.

Eligibility Criteria

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: collaborator

University of Georgia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James MacKillop, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Locations

Experimental and Clinical Psychopharmacology Laboratory, Dept. of Psychology, University of Georgia

Athens, Georgia, United States

Countries

United States

Other Identifiers

R21AA017696

Identifier Type: NIH

Identifier Source: secondary_id

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R21AA017696

Identifier Type: NIH

Identifier Source: org_study_id

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