The Effect of Yohimbine on Cocaine Cue Reactivity
Condition: Cocaine Related Disorders
MeSH terms: Cocaine-Related Disorders
Intervention: Yohimbine; Placebo
Intervention description: Participants were pre-treated with either yohimbine or placebo.
Intervention MeSH terms: Yohimbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cocaine Addiction; Cocaine Dependence

Summary:

      Stress and cues reminiscent of cocaine use promote craving and relapse in cocaine dependent
      individuals. In addition, there appears to be gender differences in determinants of relapse
      to drug use following abstinence in cocaine-dependent individuals. Therefore the purpose of
      the present study is to study the role of hormonal status on the response to cocaine-related
      cues with or without stress in cocaine-dependent women and men.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be able to provide informed consent and function at an intellectual
             level sufficient to allow accurate completion of all assessment instruments.

          -  Subjects must consent to remain abstinent from all drugs of abuse (except nicotine)
             for a three-day period immediately prior to the CTRC admission. Nicotine dependence
             can affect HPA function (Baron et al., 1995) therefore it would be ideal to exclude
             subjects with nicotine use. Because of the high comorbidity of cocaine and nicotine
             dependence, this would seriously compromise the feasibility of recruitment.
             Individuals with alcohol dependence will be excluded. However because of the high
             comorbidity of alcohol use and cocaine dependence, individuals with alcohol abuse will
             be included. Also, due to the high comorbidity of cocaine and marijuana dependence,
             and limited evidence that marijuana use affects HPA function, subjects with marijuana
             dependence will be included.

          -  Subjects with ADHD will be included. Because ADHD is commonly characterized by
             impulsivity, ADHD severity ratings will be determined and controlled for in data
             analysis.

          -  Subjects must consent to random assignment.

          -  Subjects must consent to outpatient admission to the CTRC and two overnight admissions
             to the Medical University Hospital.

        Exclusion Criteria:

          -  Women who are pregnant, nursing or of childbearing potential and not practicing an
             effective means of birth control.

          -  Women with premenstrual dysphoric disorder as this may impact on the response to the
             stress test procedure (Woods et al., 1994).

          -  Women receiving depot medroxyprogesterone acetate as a form of birth control.

          -  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 physiological/subjective responses.

          -  Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal
             cortex likely to affect hormonal/neuroendocrine status.

          -  Subjects with a history of or current psychotic disorder or bipolar affective disorder
             as these may interfere with subjective measurements.

          -  Subjects with current major depressive disorder or post-traumatic stress disorder as
             these disorders are associated with characteristic changes in stress response.

          -  Subjects with panic disorder, as yohimbine may precipitate panic attacks.

          -  Subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or
             treatment with other agents that interfere with hormonal measurements within one month
             of test session.

          -  Subjects taking any psychotropic medications,antidepressants, opiates or opiate
             antagonists because these may affect test response. Subjects taking SSRI's will be
             included.

          -  Subjects with any acute illness or fever. Individuals who otherwise meet study
             criteria will be rescheduled for evaluation for participation.

          -  Subjects who are obese (BMI>35) as this may interfere with hormonal status.

          -  Subjects who are unwilling or unable to maintain abstinence from alcohol and other
             drugs of abuse (except nicotine) for three days prior to the stress task procedure.

          -  Subjects meeting DSM-IV criteria for substance dependence (other than nicotine,
             alcohol, marijuana or cocaine as appropriate) within the past 60 days.