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Effect of Oxytocin on Stress in Marijuana Users

Primary Purpose

Marijuana Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Saline
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Dependence focused on measuring marijuana, substance abuse, drug abuse, marijuana dependence, drug addiction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 marijuana dependence (within the past three months). While individuals may also meet criteria for abuse of other substances, they must identify marijuana as their primary substance of abuse and must not meet criteria for dependence on any other substance (except nicotine) within the last 60 days.
  • Subjects must consent to remain abstinent from all drugs of abuse (except nicotine and marijuana) for a three-day period immediately prior to the CTRC admission. Subjects must abstain from marijuana for 24 hours prior to testing. By restricting marijuana use as proposed, subjects should not be under the acute effects of marijuana, and also may be experiencing mild withdrawal symptoms, the measurement of which is one of the outcome variables being tested.
  • Subjects must consent to random assignment.

Exclusion Criteria:

  • Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
  • 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.
  • 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 psychotropic medications, including SRI's or other antidepressants, opiates or opiate antagonists because these may affect test response.
  • Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.
  • Subjects who are obese (³ 20% over ideal weight) as this may interfere with hormonal status.
  • 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.
  • Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or marijuana) within the past 60 days.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oxytocin

saline

Arm Description

intranasal administration

intranasal administration

Outcomes

Primary Outcome Measures

Stress (as Measured by Cortisol)
Salivary cortisol samples were collected via passive drool to provide empirical assessment of stress reactivity. Reported here is salivary cortisol level 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.
Stress (as Measured by Subjective Report)
Subjective report of stress was measured using a 0-10 Likert Scale (0=not at all, 10=extremely). Reported here is subjective stress level 5 minutes following exposure to the Trier Social Stress Task (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.

Secondary Outcome Measures

Craving (as Measured by the Marijuana Craving Questionnaire)
The MCQ is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1-7 with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. Reported here is MCQ composite score 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.

Full Information

First Posted
April 8, 2011
Last Updated
December 10, 2015
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01335789
Brief Title
Effect of Oxytocin on Stress in Marijuana Users
Official Title
Effect of Oxytocin on Stress Response in Marijuana-dependent Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate how people who frequently use marijuana respond to a stressful task, and if a medication (oxytocin) affects this response.
Detailed Description
Stress is commonly associated with drug craving and relapse in substance-dependent individuals. Several studies indicate that hypothalamic neuropeptides may mediate behavioral response to stress. For example, preclinical and clinical investigations have indicated that the neuropeptide oxytocin exerts anxiolytic effects in stress paradigms. Several studies have indicated that oxytocin promotes trust, social bonding, and calmness; however, little is known about the potential anxiolytic affects of oxytocin in marijuana-dependent individuals. A preclinical study investigating the effects and mechanism of lithium on cannabinoid withdrawal in rats had positive findings, with increasing oxytocin levels hypothesized to moderate this effect (Cui et al, 2001). Given the anxiolytic nature of oxytocin, it may have a therapeutic role in ameliorating the negative affect commonly observed prior to relapse in marijuana-dependent individuals, as well as the anxiety associated with marijuana withdrawal. This pilot protocol will provide important preliminary data on the effect of oxytocin on stress in marijuana-dependent individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Dependence
Keywords
marijuana, substance abuse, drug abuse, marijuana dependence, drug addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin
Arm Type
Active Comparator
Arm Description
intranasal administration
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
intranasal administration
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
40 IUs
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
40 IUs
Primary Outcome Measure Information:
Title
Stress (as Measured by Cortisol)
Description
Salivary cortisol samples were collected via passive drool to provide empirical assessment of stress reactivity. Reported here is salivary cortisol level 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.
Time Frame
5 minutes following Trier Social Stress Task completion
Title
Stress (as Measured by Subjective Report)
Description
Subjective report of stress was measured using a 0-10 Likert Scale (0=not at all, 10=extremely). Reported here is subjective stress level 5 minutes following exposure to the Trier Social Stress Task (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.
Time Frame
5 minutes following Trier Social Stress Task completion
Secondary Outcome Measure Information:
Title
Craving (as Measured by the Marijuana Craving Questionnaire)
Description
The MCQ is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1-7 with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. Reported here is MCQ composite score 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.
Time Frame
5 minutes following Trier Social Stress Task completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 marijuana dependence (within the past three months). While individuals may also meet criteria for abuse of other substances, they must identify marijuana as their primary substance of abuse and must not meet criteria for dependence on any other substance (except nicotine) within the last 60 days. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine and marijuana) for a three-day period immediately prior to the CTRC admission. Subjects must abstain from marijuana for 24 hours prior to testing. By restricting marijuana use as proposed, subjects should not be under the acute effects of marijuana, and also may be experiencing mild withdrawal symptoms, the measurement of which is one of the outcome variables being tested. Subjects must consent to random assignment. Exclusion Criteria: Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control. 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. 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 psychotropic medications, including SRI's or other antidepressants, opiates or opiate antagonists because these may affect test response. Subjects with any acute illness or fever. Individuals who otherwise meet study criteria will be rescheduled for evaluation for participation. Subjects who are obese (³ 20% over ideal weight) as this may interfere with hormonal status. 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. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or marijuana) within the past 60 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee McRae-Clark, Pharm.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Effect of Oxytocin on Stress in Marijuana Users

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