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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals

Overview

Status
Completed
Phase
Phase 2
Enrollment
33 participants (actual)
Sponsor
Medical University of South Carolina · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Jul 2011
Primary completion
Oct 2012
Completion
Oct 2012
First posted
16 Oct 2013 (estimated)
Last update posted
4 Jun 2018
Conditions
Cocaine Dependence

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013
  1. Ph 2

    Effect of Oxytocin on Stress Response in Cocaine-dependent Individuals

    NCT01963091

    Jul 2011 to Oct 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • oxytocinDrug
  • salineDrug

Arms2

  • Experimental

    oxytocin

  • Placebo comparator

    placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Salivary Cortisol Levels

    Time frame · 0 minutes post 15 minute stress task

    Registry description

    salivary cortisol

Secondary outcomes(2)
  1. Likert Scale Rating of Subjective Stress

    Time frame · 0 minutes post 15 minute stress task

    Registry description

    Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'

  2. Likert Scale Rating of Subjective Craving

    Time frame · 0 mintues post 15 minute stress task

    Registry description

    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'

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 0 minutes post 15 minute stress task

Salivary Cortisol Levels

GroupValue (mg/dl)Spread
Oxytocin0.180.09
Placebo0.220.09
Secondary and other outcome results(2)
Secondary outcomeMean· 0 minutes post 15 minute stress task

Likert Scale Rating of Subjective Stress

GroupValue (units on a scale)Spread
Oxytocin4.183.49
Placebo4.252.93
Secondary outcomeMean· 0 mintues post 15 minute stress task

Likert Scale Rating of Subjective Craving

GroupValue (units on a scale)Spread
Oxytocin3.354.03
Placebo3.132.80

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Oxytocinoxytocin: 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.–0 / 170 / 17
Placebosaline: 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.–0 / 160 / 16

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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