Trial record 2 of 2 for:    heinrichs oxytocin

Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Megan Moran-Santa Maria, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01963091
First received: July 13, 2011
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Cocaine Dependence
Drug: oxytocin
Drug: saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Salivary Cortisol Levels [ Time Frame: 0 minutes post 15 minute stress task ] [ Designated as safety issue: No ]
    salivary cortisol


Secondary Outcome Measures:
  • Likert Scale Rating of Subjective Stress [ Time Frame: 0 minutes post 15 minute stress task ] [ Designated as safety issue: No ]
    Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'

  • Likert Scale Rating of Subjective Craving [ Time Frame: 0 mintues post 15 minute stress task ] [ Designated as safety issue: No ]
    Subjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely'


Enrollment: 33
Study Start Date: July 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oxytocin Drug: oxytocin
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.
Other Name: pitocin
Placebo Comparator: placebo Drug: saline
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963091

Locations
United States, South Carolina
Clinical Neurosciences Division-MUSC
Charleston, South Carolina, United States
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Megan Moran-Santa Maria, Ph.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Megan Moran-Santa Maria, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01963091     History of Changes
Other Study ID Numbers: Pro00009981
Study First Received: July 13, 2011
Results First Received: December 18, 2013
Last Updated: December 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014