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| ID | Type | Description | Link |
|---|---|---|---|
| K12HD055885 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Oxytocin is a promising new medication found to have positive effects on prosocial behavior, reduce negative affect such as fear and anxiety, and reduce stress-induced addictive behaviors. This study aims to investigate the extent to which a 40 IU dose of intranasal oxytocin improves couples' conflict resolution skills and subjective, physiological, and neuroendocrine responses to conflict. Conflict resolution discussions will take place in the laboratory and will be videotaped.
Substance use disorders (SUD) are characterized by dysregulation of the hypothalamic-pituitary axis (HPA). The neuropeptide oxytocin, commonly administered as an intranasal spray, is a drug that has prominent anxiolytic and prosocial effects on human behaviors. While the mechanisms of action facilitating the behavioral effects of oxytocin in humans is complex and many questions about this process remain, there is a consensus in the existing literature that oxytocin modulates HPA axis reactivity to stressful social stimuli. Preliminary studies suggest that oxytocin is known to reduce couple conflict among normative couples. A more developed line of research indicates that oxytocin mitigates addictive behaviors in the context of various drugs of abuse. Given the high prevalence and severity of dyadic conflict among couples where one or both partner has substance abuse, and given the salience of dyadic conflict as a precipitant to substance use behaviors, it is critical to investigate the therapeutic effects of oxytocin among couples with substance use problems. Namely, oxytocin holds promise as a potential augmenter for conjoint couples therapies, particularly those targeting the reduction of substance use problems. However, only two studies have examined the effects of oxytocin on couples' communication behaviors. Those two studies found that couples' communication skills improved following the administration of oxytocin. It is important to extend this line of research to examine conflict resolution skills among couples with substance use problems. To date, no studies have examined the effects of oxytocin on subjective, physiological, or neuroendocrine reactivity to dyadic conflict. The present study aims to fill that gap in the literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Experimental | Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin. |
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| Placebo | Placebo Comparator | Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug |
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| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Frequency of Distress Maintaining Attributions | Couples' conflict resolution discussions are video recorded and coded according to an observational coding system: the Rapid Marital Interaction Coding System, which assesses the frequency of behaviors (distress maintaining attributions and relationship enhancing attributions) during the 10 minute conflict resolution discussion. This variable is operationalized as the number of instances of distress maintaining attributions during each of two ten minute conflict resolution discussions. | Frequency of distress maintaining attrbibutions per 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Salivary Cortisol (μg/dL) | Cortisol samples are collected at baseline, pre-post each conflict resolution discussion, and at 15, 30, and 60 minute post-task intervals. | Measured at 7 time points: Baseline, immediately before and after Conflict Resolution Task #1, Immediately after Conflict Resolution Task #2, and at 15, 30, and 60 minutes following the completion of Conflict Resolution task #2. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin | Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin. Oxytocin |
| FG001 | Placebo | Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo. Placebo: Placebo for Oxytocin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin | Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin. Oxytocin |
| BG001 | Placebo | Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo. Placebo: Placebo for Oxytocin |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Frequency of Distress Maintaining Attributions | Couples' conflict resolution discussions are video recorded and coded according to an observational coding system: the Rapid Marital Interaction Coding System, which assesses the frequency of behaviors (distress maintaining attributions and relationship enhancing attributions) during the 10 minute conflict resolution discussion. This variable is operationalized as the number of instances of distress maintaining attributions during each of two ten minute conflict resolution discussions. | Analyses were limited to heterosexual couples with reliable data reporting in order to accommodate the data analytic approach (i.e., multilevel modeling). | Posted | Mean | Standard Deviation | distress maintaining attributions | Frequency of distress maintaining attrbibutions per 10 minutes |
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1 year, 3 months
This study employed the same adverse event definition as clinicaltrials.gov
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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 | Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin. Oxytocin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julianne Flanagan | Medical University of South Carolina | 843-792-5569 | Hellmuth@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2015 | Apr 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Drug |
Placebo for Oxytocin |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Two same-sex couples were excluded from analyses to accommodate multi-level modeling approach. one couple was excluded from analyses due to questionable reliability of data. | Count of Participants | Participants |
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| Race (NIH/OMB) | Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data. | Count of Participants | Participants |
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| OG001 | Placebo | Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo. Placebo: Placebo for Oxytocin |
|
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| Secondary | Change in Salivary Cortisol (μg/dL) | Cortisol samples are collected at baseline, pre-post each conflict resolution discussion, and at 15, 30, and 60 minute post-task intervals. | Three couples (6 total participants) were not included in analyses. | Posted | Mean | Standard Deviation | μg/dL | Measured at 7 time points: Baseline, immediately before and after Conflict Resolution Task #1, Immediately after Conflict Resolution Task #2, and at 15, 30, and 60 minutes following the completion of Conflict Resolution task #2. |
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| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Placebo | Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo. Placebo: Placebo for Oxytocin | 0 | 34 | 0 | 34 | 0 | 34 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Time 3 (Post Conflict Discussion #1) |
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| Time 4 (Post Conflit Discussion #2) |
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| Time 5 (15 minutes Post Conflict Discussion) |
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| Time 6 (30 minutes Post Conflict Discussion) |
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| Time 7 (60 Minutes Post Conflict Discussion) |
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