Marijuana DependenceNCT01335789
Effect of Oxytocin on Stress in Marijuana Users
A study testing Oxytocin and Saline in people with Marijuana Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Marijuana Dependence
- What is being tested?
- Oxytocin and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Effect of Oxytocin on Stress Response in Marijuana-dependent Individuals
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.
Read the 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.
- Conditions
- Marijuana Dependence
- Being tested
- Oxytocin, Saline
- Keywords
- marijuana, substance abuse, drug abuse, marijuana dependence, drug addiction
- Medical subject headings
- Marijuana Abuse, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
40 IUs
SalineDrug
40 IUs
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | intranasal administration Receives: Drug: Oxytocin |
| saline | Placebo comparator | intranasal administration Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes following Trier Social Stress Task completion
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.
Measured: 5 minutes following Trier Social Stress Task completion
Secondary outcomes (1)
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.
Measured: 5 minutes following Trier Social Stress Task completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Marijuana DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimee McRae-Clark, Medical University of South Carolina
- Investigators
- Aimee McRae-Clark, Pharm.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335789
- Sponsor's protocol ID
- 20274
- Status last verified
- Dec 2015
- First submitted
- 8 Apr 2011
- Last updated
- 14 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxytocin on Stress Response in Marijuana-dependent Individuals
- ClinicalTrials.gov ID
- NCT01335789
- Acronym / sponsor ID
- 20274
- Conditions
- Marijuana Dependence
- Keywords
- marijuana, substance abuse, drug abuse, marijuana dependence, drug addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: Oxytocinintranasal administration |
| saline | Placebo comparator | Drug: Salineintranasal administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: Pitocin40 IUs | Drug | Oxytocin |
| Saline40 IUs | Drug | saline |
Primary outcome
Stress (as Measured by Cortisol)
Time frame: 5 minutes following Trier Social Stress Task completion
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
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.
1 secondary outcome
Craving (as Measured by the Marijuana Craving Questionnaire)
Time frame: 5 minutes following Trier Social Stress Task completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aimee McRae-Clark, Pharm.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin and Saline in people with Marijuana Dependence, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (as Measured by Cortisol) (time frame: 5 minutes following Trier Social Stress Task completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.