Alcohol Use DisorderPhase 2NCT03846505
Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)
A Phase 2 study testing Oxytocin in people with Alcohol Use Disorder and Couples, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol Use Disorder, Couples
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2019to 31 Jan 2024
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female; any race or ethnicity; aged 18-75 years.
- 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).
- Married, cohabiting, or in a committed relationship for ≥ 6 months.
- 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.
- Concurrent substance use disorders (e.g., marijuana) are acceptable provided that alcohol is the IP's primary substance of choice.
- 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.
Who cannot join
- 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.
- Participants who present a serious suicide risk or are likely to require hospitalization during the study.
- 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.
- 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.
- Severe unilateral intimate partner violence in the past 6 months as defined by the Revised Conflict Tactics Scale (CTS-2).
- Pregnancy or breastfeeding for women.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29401
About this study
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.
- Conditions
- Alcohol Use Disorder, Couples
- Being tested
- Oxytocin, Placebo
- Keywords
- Couple, Alcohol, Therapy
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.
PlaceboOther
Also called Saline
A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oxytocin |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start16 May 2019
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
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 Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Oxytocin and Therapy Placebo and Therapy
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Julianne Flanagan, Medical University of South Carolina
- Investigators
- Julianne Flanagan, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846505
- Sponsor's protocol ID
- Pro00082233
- Other IDs
- 1R01AA027212
- Status last verified
- Jan 2025
- First submitted
- 17 Feb 2019
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)
- ClinicalTrials.gov ID
- NCT03846505
- Acronym / sponsor ID
- Pro00082233
- Conditions
- Alcohol Use Disorder, Couples
- Keywords
- Couple, Alcohol, Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 16 May 2019 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Oxytocin and Therapy Placebo and Therapy
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: 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. |
| Placebo | Placebo comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female; any race or ethnicity; aged 18-75 years.
- 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).
- Married, cohabiting, or in a committed relationship for ≥ 6 months.
- 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.
- Concurrent substance use disorders (e.g., marijuana) are acceptable provided that alcohol is the IP's primary substance of choice.
Key exclusion criteria (7 listed)
- 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.
- Participants who present a serious suicide risk or are likely to require hospitalization during the study.
- 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.
- 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.
- Severe unilateral intimate partner violence in the past 6 months as defined by the Revised Conflict Tactics Scale (CTS-2).
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: PitocinA 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session. | Drug | Oxytocin |
| PlaceboAlso: SalineA placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. | Other | Placebo |
Primary outcome
Change in Percent Days Abstinent - Measured by Time Line Follow Back (TLFB)
Time frame: Baseline to week 12
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
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Julianne Flanagan, PhD 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 Phase 2 study testing Oxytocin in people with Alcohol Use Disorder and Couples, 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 6 inclusion and 7 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 21 Feb 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2025). 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?
Change in Percent Days Abstinent - Measured by Time Line Follow Back (TLFB) (time frame: Baseline to week 12). The study lists 3 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 21 Feb 2025.