D-Cycloserine and Cue Exposure in Cocaine-Dependent Individuals
Condition: Cocaine Use Disorders
Intervention: D-cycloserine; Placebo
Intervention description: 50 mg DCS; Placebo
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: substance related disorders

Summary:

      In summary, this pilot study will explore the use of an innovative pharmacologic approach to
      the treatment of substance dependence through the facilitation of extinction of response to
      cocaine-conditioned cues in cocaine-dependent individuals. If DCS proves successful in this
      preliminary study, a controlled treatment trial will be planned. This novel approach could
      have implications for the treatment of multiple substance use disorders including
      methamphetamine, marijuana and opiate 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 within the past 60 days
             with the exception of nicotine. Because of the high comorbidity of cocaine and
             nicotine dependence, excluding nicotine dependence would seriously compromise the
             feasibility of recruitment. Nicotine use immediately prior to the testing session will
             be controlled. Alcohol has also been known to affect HPA function, however to enhance
             recruitment efforts individuals with alcohol dependence or abuse will be included in
             the study if they do not require medically supervised detoxification.

          3. Use of one of the following methods of birth control by female subjects: 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 our research program and have reliable
             transportation.

          5. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine or
             alcohol) for 24 hours immediately prior to the GCRC admission.

          6. Subjects must consent to random assignment to the DCS vs. placebo conditions.

        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
             diabetes, as these conditions may affect heart rate or skin conductance measurement.

          3. Individuals with creatinine clearance of 1.2 or greater as DCS is renally excreted.

          4. 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.

          5. Subjects who are unwilling or unable to maintain abstinent from alcohol and other
             drugs of abuse (except nicotine) for 24 hours days prior to the cue procedure.

          6. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or
             cocaine as appropriate) within the past 60 days.

          7. Subjects currently taking B-blockers, anti-arrythmic agents, psychostimulants or any
             other agents known to interfere with heart rate and skin conductance monitoring.

          8. Known or suspected hypersensitivity to DCS.

          9. Individuals taking medications that could adversely interact with study medications,
             including, but not limited to ethionamide, isoniazid, or amino acid supplements.

         10. Subjects with a history of epilepsy or seizure disorder.

         11. Subjects with significant liver impairment as DCS may increase serum transaminases.