Oxytocin in Cocaine Dependence

NCT01573273 | Completed Results DMC

• 1 other identifier: 00016890
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cocaine Dependence

Keywords

cocaine; substance abuse; drug abuse; cocaine dependence; drug addiction

Outcome Measures

Primary Outcomes (3)

• Subjective Stress Response TSST

  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

  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

  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 Outcomes (3)

• Subject Cocaine Craving TSST

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

• Subject Cocaine Craving MRI 1

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

• Subject Cocaine Craving MRI 2

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

Study Arms (12)

TSST Women Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

TSST Women Placebo

PLACEBO COMPARATOR

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

Drug: Saline

MRI 1 Women Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

MRI 1 Women Placebo

PLACEBO COMPARATOR

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

Drug: Saline

MRI 2 Women Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

MRI 2 Women Placebo

PLACEBO COMPARATOR

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

Drug: Saline

TSST Men Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

TSST Men Placebo

PLACEBO COMPARATOR

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

Drug: Saline

MRI I Men Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

MRI I Men Placebo

PLACEBO COMPARATOR

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

Drug: Saline

MRI 2 Men Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

MRI 2 Men Placebo

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Oxytocin DRUG

intranasal administration, 40 IUs

Also known as: pitocin

MRI 1 Women Oxytocin; MRI 2 Men Oxytocin; MRI 2 Women Oxytocin; MRI I Men Oxytocin; TSST Men Oxytocin; TSST Women Oxytocin

Saline DRUG

intranasal administration, 40 IUs

Also known as: pitocin

MRI 1 Women Placebo; MRI 2 Men Placebo; MRI 2 Women Placebo; MRI I Men Placebo; TSST Men Placebo; TSST Women Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders

Interventions

Oxytocin; Sodium Chloride

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Lisa Nunn
• Organization: MUSC

jenkinli@musc.edu

843-792-0476

Study Officials

• Aimee McRae-Clark, Pharm.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 9, 2012
• Study Start: October 1, 2012
• Primary Completion: December 19, 2017
• Study Completion: December 19, 2017
• Last Updated: March 13, 2019
• Results First Posted: March 13, 2019

Record last verified: 2019-03

Locations

US (1)