D-Cycloserine to Enhance Extinction to Alcohol Cues
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | November 2010 |
| End Date: | October 2012 |
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.
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.
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).
We found this trial at
1
site
Athens, Georgia 30605
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