Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: oxytocin; saline
Intervention description: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.; Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Stress is associated with drug craving and relapse in substance-dependent individuals.
      Hormones released from the brain may mediate the behavioral response to stress. For example,
      several studies have indicated that oxytocin reduces stress in laboratory stress paradigms.
      Specifically, it appears that oxytocin promotes trust, social interaction, and calmness; yet,
      little is known about the potential affects of oxytocin in cocaine-dependent individuals.
      Given these properties of oxytocin, it may have a therapeutic role in ameliorating the
      negative affect commonly observed prior to relapse in cocaine-dependent individuals, as well
      as the anxiety associated with withdrawal. This pilot protocol will provide important
      preliminary data on the effect of oxytocin on stress in cocaine-dependent individuals.
    

Eligibility criteria:

        1) General Inclusion / Exclusion 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 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 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. In addition, because of the high
             comorbidity of alcohol use and cocaine dependence, individuals with alcohol abuse and
             dependence will be included if they do not require medically supervised
             detoxification. Due to the high comorbidity of cocaine and marijuana dependence,
             individuals with marijuana dependence will be included.

          3. Subjects must consent to random assignment.

          4. Subjects must consent to outpatient admission to the CTRC.

        Exclusion Criteria

          1. Women who are pregnant, nursing or of childbearing potential and not practicing an
             effective means of birth control.

          2. Women with premenstrual dysphoric disorder as this may impact on the response to the
             stress test procedure.

          3. 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.

          4. Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal
             cortex likely to affect hormonal/neuroendocrine status.

          5. Subjects with a history of or current psychotic disorder or bipolar affective disorder
             as these may interfere with subjective measurements.

          6. Subjects with current major depressive disorder or post-traumatic stress disorder as
             these disorders are associated with characteristic changes in stress response.

          7. 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.

          8. Subjects taking any psychotropic medications, opiates or opiate antagonists because
             these may affect test response. Subjects who have been maintained on SSRI's for 8
             weeks will not be excluded.

          9. Subjects with any acute illness or fever. Individuals who otherwise meet study
             criteria will be rescheduled for evaluation for participation.

         10. Subjects who are > 30% over ideal weight or have a BMI greater than 35 will be
             considered for study participation based on the clinical judgment of study staff.

         11. 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.

         12. Subjects meeting DSM-IV criteria for substance dependence (other than alcohol,
             nicotine, marijuana orcocaine) within the past 60 days.