Primary outcomeMean· 5 minutes following Trier Social Stress Task completion
Stress (as Measured by Cortisol)
| Group | Value (nmol/L) |
|---|---|
| Oxytocin | 1.8 |
| Saline | 2.1 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataEffect of Oxytocin on Stress in Marijuana Users
NCTNCT01335789 (opens ClinicalTrials.gov in a new tab)Other id20274
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 16 participants (actual)
- Sponsor
- Medical University of South Carolina · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Mar 2011
- Primary completion
- Jul 2012
- Completion
- Jul 2012
- First posted
- 14 Apr 2011 (estimated)
- Last update posted
- 14 Dec 2015 (estimated)
- Conditions
- Marijuana Dependence
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201120122013
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- OxytocinDrug
- SalineDrug
Arms2
Active comparator
Oxytocin
intranasal administration
Placebo comparator
saline
intranasal administration
Primary outcomes2
Outcomes the sponsor listed as primary.
Stress (as Measured by Cortisol)
Time frame · 5 minutes following Trier Social Stress Task completion
Registry 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.
Stress (as Measured by Subjective Report)
Time frame · 5 minutes following Trier Social Stress Task completion
Registry 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.
Secondary outcomes(1)
Craving (as Measured by the Marijuana Craving Questionnaire)
Time frame · 5 minutes following Trier Social Stress Task completion
Registry 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.
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· 5 minutes following Trier Social Stress Task completion
Stress (as Measured by Subjective Report)
| Group | Value (units on a scale) |
|---|---|
| Oxytocin | 2.4 |
| Saline | 3.0 |
Secondary and other outcome results(1)
Secondary outcomeMean· 5 minutes following Trier Social Stress Task completion
Craving (as Measured by the Marijuana Craving Questionnaire)
| Group | Value (units on a scale) |
|---|---|
| Oxytocin | 41.1 |
| Saline | 53.4 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Oxytocinintranasal administration Oxytocin: 40 IUs | – | 0 / 8 | 1 / 8 |
| Salineintranasal administration Saline: 40 IUs | – | 0 / 8 | 2 / 8 |
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:
* 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.
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