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The purpose of this study is to examine the impact of a medication called oxytocin on marijuana use and therapy response in people who frequently use marijuana.
Oxytocin has been shown to promote trust, social bonding, and calmness; however, its potential additive effects with a therapy intervention have not been explored in marijuana-dependent individuals. In the proposed study, the impact of intranasal oxytocin on therapy effectiveness and marijuana use outcomes following a brief therapy intervention will be investigated. It is hypothesized that oxytocin administration (vs. placebo) will improve treatment satisfaction and decrease marijuana use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Active Comparator | intranasal administration |
|
| Saline | Placebo Comparator | intranasal administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapy Session Satisfaction (as Measured by Subjective Report) | After MET sessions, subjects completed the Session Rating Scale (SRS, Miller et al). This visual analog scale is comprised of 4 items for which participants rate their therapy experience in terms of relationship, goals and topics, approach/method, and overall, with minimum score 0 representing most dissatisfied and maximum score 10 representing most satisfied. Outcome measure reported below represents SRS score at last MET session. | Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at last session visit |
| Measure | Description | Time Frame |
|---|---|---|
| Marijuana Use (as Measured by Subjective Report of Number of Daily Smoking Sessions ) | Subjects' marijuana use was measured via self-report of number of smoking sessions per day (Time Line Followback). The average number of daily sessions were calculated per group, with data presented below representing the change in amount of daily smoking sessions per group from first MET session to last MET session. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aimee L McRae-Clark, PharmD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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Participants recruited between July 2014 and May 2015 primarily through media and internet advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin | intranasal administration Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET. |
| FG001 | Saline | intranasal administration Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin | intranasal administration Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET. |
| BG001 | Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Therapy Session Satisfaction (as Measured by Subjective Report) | After MET sessions, subjects completed the Session Rating Scale (SRS, Miller et al). This visual analog scale is comprised of 4 items for which participants rate their therapy experience in terms of relationship, goals and topics, approach/method, and overall, with minimum score 0 representing most dissatisfied and maximum score 10 representing most satisfied. Outcome measure reported below represents SRS score at last MET session. | Posted | Mean | Standard Error | units on a scale | Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at last session visit |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin | intranasal administration Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
Limitations included small sample size and limited generalizability as individuals with other substance use disorders were excluded from participation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aimee McRae-Clark | MUSC | 843-792-5216 | mcraeal@musc.edu |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Saline | Drug | Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET. |
|
|
| Self-report of average daily smoking sessions at MET Session 1 and last MET session 3 |
intranasal administration
Saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Saline |
intranasal administration Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET. |
|
|
| Secondary | Marijuana Use (as Measured by Subjective Report of Number of Daily Smoking Sessions ) | Subjects' marijuana use was measured via self-report of number of smoking sessions per day (Time Line Followback). The average number of daily sessions were calculated per group, with data presented below representing the change in amount of daily smoking sessions per group from first MET session to last MET session. | Posted | Mean | Standard Error | daily smoking sessions | Self-report of average daily smoking sessions at MET Session 1 and last MET session 3 |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Saline | intranasal administration Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET. | 0 | 8 | 2 | 8 |
| Other | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |