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| ID | Type | Description | Link |
|---|---|---|---|
| R21AA017696 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Boston University | OTHER |
| Brown University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Inert filler in matched pill. |
|
| d-cycloserine 50 mg | Active Comparator | 50 mg d-cycloserine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| d-cycloserine. | Drug | 50 mg administered on two occasions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Craving for alcohol. | 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tolerability | Side effects resulting from d-cycloserine in individuals with alcohol use disorders. | Prevalence and change in side effects measured on 4 occasions (Study Day: 1, 4, 7, 12) |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James MacKillop, PhD | University of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Experimental and Clinical Psychopharmacology Laboratory, Dept. of Psychology, University of Georgia | Athens | Georgia | 30605 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 8, 2017 | |
| Reset | Oct 4, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 8, 2017 | Oct 4, 2017 |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |