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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA027212 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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Alcohol Behavioral Couples Therapy (ABCT) is a manualized 12-session, weekly psychosocial intervention that simultaneously reduces alcohol use disorder (AUD) severity and improves relationship functioning. However, there remains room to improve ABCT outcomes. A growing literature suggests that intranasal oxytocin is a medication that holds promise to achieve that goal. Oxytocin has demonstrated the ability to increase prosocial behavior (e.g., trust, safety, social cognition) and restore sensitivity to natural rewards such as interpersonal relationships that are commonly eroded in the context of addiction. Oxytocin has also demonstrated the ability to reduce substance use behaviors (e.g., craving, self-administration, tolerance, withdrawal), and improves the neurobiological foundations of AUD. The primary objective of this Stage II study is to test the efficacy of oxytocin versus placebo in improving (1) AUD symptom severity, (2) relationship functioning, and (3) corticolimbic connectivity among couples receiving ABCT therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Experimental | A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. |
|
| Placebo | Placebo Comparator | A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent Days Abstinent - Measured by Time Line Follow Back (TLFB) | Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent days abstinent (days with no alcohol consumption) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of drinking days representing better outcomes. Time Line Follow Back (TLFB), a clinician assessed measure, will be used to report percent days abstinent (days with no alcohol consumption) and percent days heavy drinking (5 or more days of binge drinking per month). | Baseline to week 12 |
| Change in Relationship Functioning - Measured by Dyadic Adjustment Scale - Short Form (DAS-7) | Change in relationship functioning was measured by the Dyadic Adjustment Scale - Short Form (DAS-7), 7-item Likert-type self-report measure assessing four relationship domains (satisfaction, intimacy, affective expression, and agreement). The DAS-7 was administered at baseline and weekly for 12 weeks (end of treatment). Scores range from 0-36, with higher scores representing better relationship functioning. | Baseline to week 12 |
| Change in Percent Days Heavy Drinking - Measured by Time Line Follow Back (TLFB) | Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent heavy drinking days defined in a sex-specific manner (> 4 standard drinks for women or > 5 for men) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of heavy drinking days representing better outcomes. | Baseline to week 12 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Julianne Flanagan, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29401 | United States |
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Participants were 96 adult romantic couples (total N=192) where at least one partner met diagnostic criteria for Alcohol Use Disorder in the past 6 months.Couples were required to have been in their current relationship for at least 6 months. Participants who were taking psychotropic medications were required to be on a stable dose for 4 weeks before enrolling.
Participants were recruited through internet advertisements, clinician referrals, and flyers. Following preliminary eligibility screening, Identified Patients and partners completed private written informed and a baseline assessment separately for privacy. The baseline assessment included a history and physical (H&P) exam and a battery of standardized self-report and interview measures.
Recruitment and enrollment occurred from May 2019 to April 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin | A 40-International Unit (IU) dose of oxytocin self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session. All participants assigned to 12 weekly, 90-minute therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. |
| FG001 | Placebo | A placebo self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session. All participants assigned to 12 weekly, 90-minute therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
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| |||||||||||||||||||||
| Completed Follow Up Phase (6-month) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin | A 40-International Unit (IU) dose of oxytocin self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session. All participants assigned to12 weekly, 90-minute therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Identified Patient and Partner listed in individual rows. |
| 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 Percent Days Abstinent - Measured by Time Line Follow Back (TLFB) | Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent days abstinent (days with no alcohol consumption) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of drinking days representing better outcomes. Time Line Follow Back (TLFB), a clinician assessed measure, will be used to report percent days abstinent (days with no alcohol consumption) and percent days heavy drinking (5 or more days of binge drinking per month). | Posted | Mean | 95% Confidence Interval | percentage of days abstinent for alcohol | Baseline to week 12 |
|
Approximately 9 months (from start of baseline appointment through 12-week treatment phase and 6 month follow up)
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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 | A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Oxytocin: A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Cardiac disorders | MedDRA 10.0 | Systematic Assessment | with hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronavirus infections | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacey Sellers, Lab Manager | Medical University of South Carolina - Institute of Psychiatry | 8437925807 | sellersst@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 | Mar 8, 2022 | Jan 16, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 16, 2022 | Jan 16, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| 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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Oxytocin and Therapy Placebo and Therapy
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Double Blind
| Placebo | Other | A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. |
|
|
| Opted out of intervention but completed assessments |
|
| NOT COMPLETED |
|
|
| Placebo |
A placebo self-administered 30 minutes prior to the start of each weekly Alcohol Behavioral Couples Therapy (ABCT) session. All participants assigned to 12 weekly, 90-minute therapy therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Identified Patient and Partner listed in individual rows. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Identified Patient and Partner listed in individual rows. | Count of Participants | Participants |
|
| OG001 | Placebo | A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Placebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. |
|
|
| Primary | Change in Relationship Functioning - Measured by Dyadic Adjustment Scale - Short Form (DAS-7) | Change in relationship functioning was measured by the Dyadic Adjustment Scale - Short Form (DAS-7), 7-item Likert-type self-report measure assessing four relationship domains (satisfaction, intimacy, affective expression, and agreement). The DAS-7 was administered at baseline and weekly for 12 weeks (end of treatment). Scores range from 0-36, with higher scores representing better relationship functioning. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to week 12 |
|
|
|
| Primary | Change in Percent Days Heavy Drinking - Measured by Time Line Follow Back (TLFB) | Change in percent days abstinent was measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview that uses calendar prompts to stimulate recall of alcohol consumption. Percent heavy drinking days defined in a sex-specific manner (> 4 standard drinks for women or > 5 for men) were measured at baseline (60 days prior to study entry) and weekly for 12 weeks (end of treatment phase), with lower percentage of heavy drinking days representing better outcomes. | Posted | Mean | 95% Confidence Interval | percentage of heavy drinking days | Baseline to week 12 |
|
|
|
| Post-Hoc | Change in Alcohol Problem Severity - Measured by Alcohol Use Disorder Identification Test (AUDIT) | Change in alcohol problem severity was measured by the Alcohol Use Disorder Identification Test (AUDIT), a 10-item Likert-type self-report measure. The AUDIT was administered at baseline and weekly for 12 weeks (end of treatment). Scores range from 0 to 40, with scores of 15 or greater representing moderate to severe Alcohol Use Disorder (AUD). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to week 12 |
|
|
|
| Post-Hoc | Changes in Patient Outcomes Based on Partners' Alcohol Use Disorder (AUD) Status - Measured by Alcohol Use Disorder Identification Test (AUDIT) | Between-group differences in patients' outcomes based on partners' alcohol use disorder (AUD) status measured by the Alcohol Use Disorder Identification Test (AUDIT), a 10-item Likert-type self-report measure. Scores range from 0-40 on the AUDIT, with higher scores representing greater problems with alcohol use, and 15 or greater representing AUD. Group differences in patient outcomes included percent days abstinent and percent days heaving drinking, measured by the Time Line Follow Back (TLFB), a semi-structured clinical interview. Outcomes also included patients' relationship functioning, measured by the Dyadic Adjustment Scale-Short Form (DAS-7), a 7-item Likert-type self-report measure, and patients' alcohol problem severity, measured by the AUDIT, a 10-item Likert-type self-report measure. DAS score ranges from 0 to 36, with a higher score indicating more positive relationship quality. Scores less than 21 are considered to indicate a relationship in distress. | Posted | Number | Cohen's D | Baseline to week 12 |
|
|
|
| 0 |
| 98 |
| 2 |
| 98 |
| 49 |
| 98 |
| EG001 | Placebo | A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual. Placebo: A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. | 0 | 94 | 6 | 94 | 38 | 94 |
| Appendectomy | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment | with hospitalization |
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| Hernia surgery | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment | with hospitalization |
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| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment | with hospitalization |
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| Suicide attempt | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment | (pills) with hospitalization |
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| Supraventricular tachycardia/arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment | with hospitalization |
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| Inpatient alcohol detoxification | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Thoracic injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment | with hospitalization |
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| Gastrointestinal discomfort | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Viral upper respiratory tract infections | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Headache/Migraine | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Injury/Accident | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment | skin burn; burned hand; broken hand; hand wound; finger laceration; facial abrasion; facial contusion; facial scrape; scratched cornea; back injury; torn rotator cuff; broken foot; foot injury; fall resulting in knee/foot abrasions |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 10.0 | 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 |
| Male |
|
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Relationship functioning |
|
| Alcohol problem severity |
|