Primary outcomeMean· Baseline to week 12
Change in Percent Days Abstinent - Measured by Time Line Follow Back (TLFB)
| Group | Value (percentage of days abstinent for alcohol) |
|---|---|
| Oxytocin | 36.8 |
| Placebo | 35.9 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataOxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 192 participants (actual)
- Sponsor
- Medical University of South Carolina · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 16 May 2019
- Primary completion
- 31 Jan 2024
- Completion
- 31 Jan 2024
- First posted
- 19 Feb 2019
- Last update posted
- 21 Feb 2025
- Conditions
- Alcohol Use Disorder · Couples
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2019202020212022202320242025
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- OxytocinDrug
- PlaceboOther
Arms2
Experimental
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.
Placebo comparator
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.
Primary outcomes3
Outcomes the sponsor listed as primary.
Change in Percent Days Abstinent - Measured by Time Line Follow Back (TLFB)
Time frame · Baseline to week 12
Registry description
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).
Change in Relationship Functioning - Measured by Dyadic Adjustment Scale - Short Form (DAS-7)
Time frame · Baseline to week 12
Registry description
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.
Change in Percent Days Heavy Drinking - Measured by Time Line Follow Back (TLFB)
Time frame · Baseline to week 12
Registry description
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 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· Baseline to week 12
Change in Relationship Functioning - Measured by Dyadic Adjustment Scale - Short Form (DAS-7)
| Group | Value (score on a scale) |
|---|---|
| Oxytocin | 25.0 |
| Placebo | 25.0 |
Primary outcomeMean· Baseline to week 12
Change in Percent Days Heavy Drinking - Measured by Time Line Follow Back (TLFB)
| Group | Value (percentage of heavy drinking days) |
|---|---|
| Oxytocin | 11.8 |
| Placebo | 9.9 |
Secondary and other outcome results(2)
Post hoc outcomeMean· Baseline to week 12
Change in Alcohol Problem Severity - Measured by Alcohol Use Disorder Identification Test (AUDIT)
| Group | Value (score on a scale) |
|---|---|
| Oxytocin | 14.6 |
| Placebo | 13.1 |
Post hoc outcomeNumber· Baseline to week 12
Changes in Patient Outcomes Based on Partners' Alcohol Use Disorder (AUD) Status - Measured by Alcohol Use Disorder Identification Test (AUDIT)
| Group | Value (Cohen's D) |
|---|---|
| Partner Has Alcohol Use Disorder (AUD) | -0.03 |
| Partner Does Not Have Alcohol Use Disorder (AUD) | 0.00 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| OxytocinA 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. | 0 / 98 | 2 / 98 | 49 / 98 |
| PlaceboA 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 |
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 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria
1. Male or female; any race or ethnicity; aged 18-75 years.
2. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments (\> 26 on the Mini-Mental State Exam).
3. Married, cohabiting, or in a committed relationship for ≥ 6 months.
4. Identified Patients (IPs) must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for current alcohol use disorder. Couples in which both partners meet diagnostic criteria for current Alcohol Use Disorder (AUD) are eligible for participation.
5. Concurrent substance use disorders (e.g., marijuana) are acceptable provided that alcohol is the IP's primary substance of choice.
6. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation. This is because initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results.
Exclusion criteria
1. Meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, or with current suicidal or homicidal ideation and intent. Those individuals will be referred clinically for treatment.
2. Participants who present a serious suicide risk or are likely to require hospitalization during the study.
3. Participants on psychotropic medications which have been initiated during the past 4 weeks. They may be re-assessed after at least four weeks on a stable dose.
4. Acute alcohol withdrawal as indicated by Clinical Institute Withdrawal Assessment Alcohol Scale Revised (CIWA-Ar) scores \>8. They may be re-assessed once they are no longer in withdrawal. Those individuals will be referred for medically supervised detoxification.
5. Severe unilateral intimate partner violence in the past 6 months as defined by the Revised Conflict Tactics Scale (CTS-2).
6. Pregnancy or breastfeeding for women.
7. Individuals with implanted metal devices above the waist will be eligible to enroll in the clinical trial but will not be eligible to participate in the neuroimaging component of the study.
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