D-Cycloserine Facilitation of Cocaine - Cue Extinction
Condition: Cocaine Use Disorders
Intervention: D-Cycloserine (DCS); Placebo
Intervention description: 50 mg d-cycloserine or placebo taken orally
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: substance-related disorders

Summary:

      The purpose of this study is to explore the use of d-cycloserine (DCS) to facilitate
      extinction of response to cocaine cues in cocaine-dependent individuals, in hopes that it may
      lead to the development of new treatment options for cocaine dependence.
    

Eligibility criteria:

        Inclusion Criteria

          1. Subjects must be able to provide informed consent and function at an intellectual
             level sufficient to allow accurate completion of all assessment instruments.

          2. Subjects must meet DSM-IV criteria for current cocaine dependence. Subjects may meet
             criteria for abuse, but not dependence on any other substance with the exceptions of
             nicotine and alcohol. Because of the high comorbidity of cocaine with alcohol and
             nicotine dependence, excluding nicotine and alcohol dependence would seriously
             compromise the feasibility of recruitment. Nicotine use immediately prior to the cue
             exposure/extinction session will be controlled. Although individuals who meet criteria
             for alcohol dependence will be accepted for study participation, anyone who has a
             measurable blood alcohol level on the day of the sessions will be excluded as acute
             alcohol intake can increase serum levels of DCS and lower the seizure threshold.

          3. Use of one of the following methods of birth control by female subjects: birth control
             pills, barrier methods (diaphragm or condoms with spermicide or both), surgical
             sterilization, use of an intra-uterine contraceptive device, or complete abstinence
             from sexual intercourse.

          4. Subjects must live within a 50-mile radius of the research facility and have reliable
             transportation.

          5. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine)
             prior to the first session and through the final session.

          6. Subjects must consent to random assignment to the DCS vs. placebo conditions.

          7. For fMRI participants, subjects must be right-handed.

        Exclusion Criteria

          1. Women who are pregnant, nursing or of childbearing potential and not practicing an
             effective means of birth control.

          2. Subjects with evidence of or a history of significant hematological, endocrine,
             cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including
             insulin-dependent diabetes, as these conditions may affect heart rate or skin
             conductance measurement.

          3. Subjects with a history of or current psychotic disorder, current major depressive
             disorder, bipolar affective disorder or a severe anxiety disorder as these may impact
             cue reactivity.

          4. Subjects who are unwilling or unable to maintain abstinence from alcohol and other
             drugs of abuse (except nicotine) prior to and between the cue procedures.

          5. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine,
             alcohol or cocaine as appropriate) within the past 60 days.

          6. Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any
             other agents known to interfere with heart rate and skin conductance monitoring.

          7. Known or suspected hypersensitivity to DCS.

          8. Individuals taking medications that could adversely interact with study medications,
             including, but not limited to ethionamide, isoniazid, or amino acid supplements.

          9. Subjects with a history of epilepsy or seizure disorder.

         10. Subjects with significant liver impairment, as DCS may increase serum transaminases.

         11. For fMRI participants, the need for maintenance or acute treatment with any
             psychoactive medication including anti-seizure medications which could potentially
             interfere with fMRI.

         12. For fMRI participants, clinically significant psychiatric or medical problems that
             would impair participation or limit ability to participate in scan.