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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Oxytocin in Cocaine Dependence

Overview

Status
Completed
Phase
Not applicable
Enrollment
112 participants (actual)
Sponsor
Medical University of South Carolina · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Oct 2012
Primary completion
19 Dec 2017
Completion
19 Dec 2017
First posted
9 Apr 2012 (estimated)
Last update posted
13 Mar 2019
Conditions
Cocaine Dependence

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015201620172018
  1. N/A

    Oxytocin in Cocaine Dependence

    NCT01573273

    Oct 2012 to 19 Dec 2017

Registry summary

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

Stress is likely involved in relapse to cocaine use. This project will investigate the role oxytocin may play in the stress response in cocaine-dependent men and women and examine how oxytocin may impact brain activity in individuals exposed to cocaine-related cues.

Interventions

  • OxytocinDrug
  • SalineDrug

Arms12

  • Experimental

    TSST Women Oxytocin

    Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.

  • Placebo comparator

    TSST Women Placebo

    Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.

  • Experimental

    MRI 1 Women Oxytocin

    Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.

  • Placebo comparator

    MRI 1 Women Placebo

    Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.

  • Experimental

    MRI 2 Women Oxytocin

    Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.

  • Placebo comparator

    MRI 2 Women Placebo

    Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.

  • Experimental

    TSST Men Oxytocin

    Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.

  • Placebo comparator

    TSST Men Placebo

    Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.

  • Experimental

    MRI I Men Oxytocin

    Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.

  • Placebo comparator

    MRI I Men Placebo

    Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.

  • Experimental

    MRI 2 Men Oxytocin

    Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.

  • Placebo comparator

    MRI 2 Men Placebo

    Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Subjective Stress Response TSST

    Time frame · Subjects rated stress immediately following a Social Stress task on Day 1 of 3.

    Registry description

    Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels.

  2. Subjective Stress Response MRI 1

    Time frame · Subjects rated Stress immediately following the first of two MRI scans on Day 2 of 3.

    Registry description

    Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels

  3. Subjective Stress Response MRI 2

    Time frame · Subjects rated stress immediately following the second of two MRI scans on Day 3 of 3.

    Registry description

    Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels.

Secondary outcomes(3)
  1. Subject Cocaine Craving TSST

    Time frame · Subjects rated craving immediately following a Social Stress task on Day 1 of 3.

    Registry description

    Subjects rated craving on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower craving.

  2. Subject Cocaine Craving MRI 1

    Time frame · Subjects rated craving immediately following the first of two MRI scans on Day 2 of 3.

    Registry description

    Subjects rated craving on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower craving.

  3. Subject Cocaine Craving MRI 2

    Time frame · Subjects rated craving immediately following the second of two MRI scans on Day 3 of 3.

    Registry description

    Subjects rated craving on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower craving.

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· Subjects rated stress immediately following a Social Stress task on Day 1 of 3.

Subjective Stress Response TSST

GroupValue (units on a scale)Spread
TSST Women Oxytocin5.333.81
TSST Women Placebo5.284.09
TSST Men Oxytocin2.052.34
TSST Men Placebo2.132.87
Primary outcomeMean· Subjects rated Stress immediately following the first of two MRI scans on Day 2 of 3.

Subjective Stress Response MRI 1

GroupValue (units on a scale)Spread
MRI 1 Women Oxytocin2.052.34
MRI 1 Women Placebo2.132.87
MRI 1 Men Oxytocin1.752.40
MRI 1 Men Placebo2.662.84
Primary outcomeMean· Subjects rated stress immediately following the second of two MRI scans on Day 3 of 3.

Subjective Stress Response MRI 2

GroupValue (units on a scale)Spread
MRI 2 Women Oxytocin0.831.67
MRI 2 Women Placebo1.832.81
MRI 2 Men Oxytocin1.072.07
MRI 2 Men Placebo1.392.06
Secondary and other outcome results(3)
Secondary outcomeMean· Subjects rated craving immediately following a Social Stress task on Day 1 of 3.

Subject Cocaine Craving TSST

GroupValue (units on a scale)Spread
TSST Women Oxytocin3.083.69
TSST Women Placebo3.243.38
TSST Men Oxytocin3.453.35
TSST Men Placebo3.453.35
Secondary outcomeMean· Subjects rated craving immediately following the first of two MRI scans on Day 2 of 3.

Subject Cocaine Craving MRI 1

GroupValue (units on a scale)Spread
MRI 1 Women Oxytocin2.893.31
MRI 1 Women Placebo2.652.81
MRI 1 Men Oxytocin3.042.70
MRI 1 Men Placebo3.692.99
Secondary outcomeMean· Subjects rated craving immediately following the second of two MRI scans on Day 3 of 3.

Subject Cocaine Craving MRI 2

GroupValue (units on a scale)Spread
MRI 2 Women Oxytocin2.172.70
MRI 2 Women Placebo2.612.78
MRI 2 Men Oxytocin2.042.38
MRI 2 Men Placebo2.292.54

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TSST Women OxytocinCocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Oxytocin: intranasal administration, 40 IUs0 / 240 / 240 / 24
TSST Women PlaceboCocaine-dependent women received intranasal saline prior to completing a Social Stress Task. Saline: intranasal administration, 40 IUs0 / 250 / 250 / 25
MRI 1 Women OxytocinCocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks. Oxytocin: intranasal administration, 40 IUs0 / 190 / 190 / 19
MRI 1 Women PlaceboCocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs0 / 230 / 230 / 23
MRI 2 Women OxytocinCocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks. Oxytocin: intranasal administration, 40 IUs0 / 230 / 230 / 23
MRI 2 Women PlaceboCocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs0 / 180 / 180 / 18
TSST Men OxytocinCocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task. Oxytocin: intranasal administration, 40 IUs0 / 320 / 320 / 32
TSST Men PlaceboCocaine-dependent men received intranasal saline prior to completing a Social Stress Task. Saline: intranasal administration, 40 IUs0 / 310 / 310 / 31
MRI I Men OxytocinCocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks. Oxytocin: intranasal administration, 40 IUs0 / 280 / 280 / 28
MRI I Men PlaceboCocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs0 / 290 / 290 / 29
MRI 2 Men OxytocinCocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks. Oxytocin: intranasal administration, 40 IUs0 / 270 / 270 / 27
MRI 2 Men PlaceboCocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks. Saline: intranasal administration, 40 IUs0 / 280 / 280 / 28

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
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 (within the past three months). While individuals may also meet criteria for abuse of other substances, they must not meet criteria for dependence on any other substance (except nicotine) within the last 60 days. Alcohol has been known to affect HPA function (Adinoff et al., 1991), 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. 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. 3. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for a three-day period immediately prior to the throughout study procedures. 4. Subjects must consent to random assignment. 5. Subjects must consent to participating in study procedures at the ASD and completion of two fMRI scans. Exclusion Criteria 1. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control (not including hormonal contraceptives). 2. Women who are currently taking, or have taken in the past month, oral or other types of hormonal contraceptives or hormone replacement therapies. 3. Women with premenstrual dysphoric disorder who are outside of the follicular phase. 4. Women who have had a complete hysterectomy or are over 50 over one year post-menopausal, as ovarian hormones will be measured in the study. 5. 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. Neurological exclusions include history of stroke, seizure disorders, multiple sclerosis, Parkinson's disease, and Alzheimer's disease. 6. Subjects with Addison's disease, Cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status. 7. Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements. 8. Subjects with current major depressive disorder or post-traumatic stress disorder as these disorders are associated with characteristic changes in stress response. 9. 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. 10. Subjects taking any mood stabilizers, antipsychotics, benzodiazepines, opiates or opiate antagonists because these may affect test response. Subjects taking SSRI's will be included. 11. Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation. 12. Subjects whose height to weight ratio would preclude them from fitting comfortably in the MRI scanner. 13. 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. 14. Persons with ferrous metal implants or pacemaker since fMRI will be used. 15. Subjects who are claustrophobic. 16. Subjects with significant psychiatric or medical problems that would impair participation or limit ability to participate in scan. 17. Subjects who require maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI. 18. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, cocaine, alcohol or marijuana) within the past 60 days.

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