- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01573273
Oxytocin in Cocaine Dependence
March 11, 2019 updated by: Aimee McRae-Clark, Medical University of South Carolina
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.
Study Overview
Detailed Description
Stress is an important predictor of relapse, and targeting stress-activated pathways may lead to therapeutic advancements in the treatment of substance use disorders.
Oxytocin has been shown to promote trust, social bonding, and calmness; however, its potential effects have not been explored in cocaine-dependent individuals.
Oxytocin receptors have been localized to brain regions that are activated by drug-paired cues and preclinical studies have shown that oxytocin attenuates the acute and long-term behavioral effects of psychostimulants.
However, little is known about the role of oxytocin in mediating the affective response to cocaine-paired cues and associated neural activity in cocaine-dependent men and women.
This project is a direct evolution from our previous SCOR-supported research.
Our work has progressed from characterizing sex/gender differences in response to social stressors and cocaine cues in cocaine-dependent men and women, to our on-going work evaluating whether stress potentiates cue-induced craving and the impact of hormones on this response.
The proposed study will investigate the role of oxytocin in the sex/gender differences in stress response and craving in cocaine-dependent individuals and preliminarily explore its therapeutic potential.
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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.
- 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.
- Subjects must consent to random assignment.
- Subjects must consent to participating in study procedures at the ASD and completion of two fMRI scans.
Exclusion Criteria
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control (not including hormonal contraceptives).
- Women who are currently taking, or have taken in the past month, oral or other types of hormonal contraceptives or hormone replacement therapies.
- Women with premenstrual dysphoric disorder who are outside of the follicular phase.
- 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.
- 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.
- 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 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 mood stabilizers, antipsychotics, benzodiazepines, 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 whose height to weight ratio would preclude them from fitting comfortably in the MRI scanner.
- 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.
- Persons with ferrous metal implants or pacemaker since fMRI will be used.
- Subjects who are claustrophobic.
- Subjects with significant psychiatric or medical problems that would impair participation or limit ability to participate in scan.
- Subjects who require maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI.
- Subjects meeting DSM-IV criteria for substance dependence (other than nicotine, cocaine, alcohol or marijuana) within the past 60 days.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TSST Women Oxytocin
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
|
intranasal administration, 40 IUs
Other Names:
|
PLACEBO_COMPARATOR: TSST Women Placebo
Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.
|
intranasal administration, 40 IUs
Other Names:
|
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.
|
intranasal administration, 40 IUs
Other Names:
|
PLACEBO_COMPARATOR: MRI 1 Women Placebo
Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.
|
intranasal administration, 40 IUs
Other Names:
|
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.
|
intranasal administration, 40 IUs
Other Names:
|
PLACEBO_COMPARATOR: MRI 2 Women Placebo
Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.
|
intranasal administration, 40 IUs
Other Names:
|
EXPERIMENTAL: TSST Men Oxytocin
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
|
intranasal administration, 40 IUs
Other Names:
|
PLACEBO_COMPARATOR: TSST Men Placebo
Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.
|
intranasal administration, 40 IUs
Other Names:
|
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.
|
intranasal administration, 40 IUs
Other Names:
|
PLACEBO_COMPARATOR: MRI I Men Placebo
Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.
|
intranasal administration, 40 IUs
Other Names:
|
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.
|
intranasal administration, 40 IUs
Other Names:
|
PLACEBO_COMPARATOR: MRI 2 Men Placebo
Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.
|
intranasal administration, 40 IUs
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Stress Response TSST
Time Frame: Subjects rated stress immediately following a Social Stress task on Day 1 of 3.
|
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.
|
Subjects rated stress immediately following a Social Stress task on Day 1 of 3.
|
Subjective Stress Response MRI 1
Time Frame: Subjects rated Stress immediately following the first of two MRI scans on Day 2 of 3.
|
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
|
Subjects rated Stress immediately following the first of two MRI scans on Day 2 of 3.
|
Subjective Stress Response MRI 2
Time Frame: Subjects rated stress immediately following the second of two MRI scans on Day 3 of 3.
|
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.
|
Subjects rated stress immediately following the second of two MRI scans on Day 3 of 3.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Cocaine Craving TSST
Time Frame: Subjects rated craving immediately following a Social Stress task on Day 1 of 3.
|
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.
|
Subjects rated craving immediately following a Social Stress task on Day 1 of 3.
|
Subject Cocaine Craving MRI 1
Time Frame: Subjects rated craving immediately following the first of two MRI scans on Day 2 of 3.
|
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.
|
Subjects rated craving immediately following the first of two MRI scans on Day 2 of 3.
|
Subject Cocaine Craving MRI 2
Time Frame: Subjects rated craving immediately following the second of two MRI scans on Day 3 of 3.
|
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.
|
Subjects rated craving immediately following the second of two MRI scans on Day 3 of 3.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (ACTUAL)
December 19, 2017
Study Completion (ACTUAL)
December 19, 2017
Study Registration Dates
First Submitted
April 5, 2012
First Submitted That Met QC Criteria
April 6, 2012
First Posted (ESTIMATE)
April 9, 2012
Study Record Updates
Last Update Posted (ACTUAL)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00016890
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cocaine Dependence
-
W. Michael HootenNational Institute on Drug Abuse (NIDA)Recruiting
-
University of ArkansasNational Institute on Drug Abuse (NIDA); Baylor College of MedicineCompleted
-
University of PennsylvaniaNational Institute on Drug Abuse (NIDA)Completed
-
Tong LeeNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)CompletedCocaine Dependence | Methamphetamine DependenceUnited States
-
University of CincinnatiNational Institute on Drug Abuse (NIDA)CompletedNicotine Dependence | Cocaine Dependence | Methamphetamine DependenceUnited States
-
The University of Texas Health Science Center,...National Institute on Drug Abuse (NIDA)RecruitingAlcohol Dependence | Substance Abuse | Cocaine Dependence | Opiate Dependence | Cocaine AbuseUnited States
-
Johns Hopkins UniversityCompletedBehavior, Addictive | Heroin Dependence | Opioid Dependence | Cocaine Dependence | Cocaine AbuseUnited States
-
Wayne State UniversityNational Institute on Drug Abuse (NIDA)CompletedOpioid-Related Disorders | Heroin Dependence | Cocaine Abuse or DependenceUnited States
-
University of PennsylvaniaCompletedCocaine DependenceUnited States
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)Active, not recruitingMethamphetamine Use Disorder | Cocaine Use Disorder | Cocaine Dependence | Methamphetamine Dependence | Stimulant Use Disorder | Methamphetamine Abuse | Cocaine Abuse | Stimulant Abuse | Stimulant UseUnited States
Clinical Trials on Oxytocin
-
University of Electronic Science and Technology...Completed
-
Hillel Yaffe Medical CenterUnknownCervix; Insufficient Dilatation in LaborIsrael
-
University of NebraskaNational Institute of Mental Health (NIMH)Terminated
-
GlaxoSmithKlineCompletedPostpartum HemorrhageUnited Kingdom
-
University of Electronic Science and Technology...Recruiting
-
GlaxoSmithKlineMonash University; InVentiv CliniqueTerminatedPostpartum HemorrhageAustralia, United Kingdom
-
University Hospital, ToulouseCompleted
-
OptiNose ASUniversity of OsloCompletedHealthy Male AdultsNorway
-
Washington University School of MedicineUniversity of MichiganRecruiting
-
Wake Forest University Health SciencesNational Institute of Neurological Disorders and Stroke (NINDS)CompletedHealthy Volunteer StudyUnited States