Posttraumatic Stress Disorder (PTSD)PROJECT COMETNCT06968832
Project COMET: Massed Prolonged Exposure for PTSD and SUD
A study testing Massed Prolonged Exposure Therapy (M-PE) and Standard outpatient SUD care in people with Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders (SUD), run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if Massed Prolonged Exposure Therapy (M-PE) can improve PTSD symptoms and reduce substance use in adults receiving intensive outpatient (IOP) treatment for substance use disorder (SUD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD), Substance Use Disorders (SUD), Comorbidity
- What is being tested?
- Massed Prolonged Exposure Therapy (M-PE) and Standard outpatient SUD care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- Enrolled in SUD treatment at Gateway Community Services
- Meet DSM-5 criteria for a SUD (Tobacco Use Disorder alone not sufficient for inclusion)
- Meet DSM-5 criteria for PTSD
- Able to give informed consent
Who cannot join
- severe cognitive impairment
- current suicidal or homicidal intent requiring immediate treatment
- current unstable psychotic or manic symptoms not attributable to SUD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denise Hien Helen E. Chaney Endowed Chair in Alcohol Studies, Ph.D contact
United States1 site, 1 recruiting
- Recruiting
Gateway Community Services
Jacksonville, Florida, 32204
Candy Hodgkins CEO - Gateway Comunity Services, Inc., Doctor of Philosophy (Ph.D.), 1-877-389-9966, chodgkins@gwjax.com
About this study
Official title: Project COMET: Hybrid Effectiveness-Implementation Trial of Massed PTSD Treatment in a Community Substance Use Program
The goal of this clinical trial is to learn if Massed Prolonged Exposure Therapy (M-PE) can improve PTSD symptoms and reduce substance use in adults receiving intensive outpatient (IOP) treatment for substance use disorder (SUD). The main questions it aims to answer are:
- Does M-PE reduce PTSD symptoms more effectively than trauma treatment as usual (TAU)?
- Does M-PE reduce the number of days participants use substances?
- How do patient-centered outcomes (such as depression, suicidal thoughts, and quality of life) differ between M-PE and trauma TAU?
- Researchers will compare M-PE to treatment as usual to see if M-PE leads to better mental health and substance use outcomes and lower dropout rates.
Read more
Participants will:
- Attend multiple therapy sessions per week (M-PE) or receive usual care
- Complete assessments at baseline, during treatment, end-of-treatment, 1-month, 3-month, and 6-month follow-up
- Share feedback through surveys and interviews about their experience in the program
Read the detailed description
Posttraumatic stress disorder (PTSD) and substance use disorder (SUD) often co-occur. PTSD+SUD comorbidity is associated with more severe PTSD, worse treatment outcomes for substance use, greater suicide risk and worse functioning than having one of these disorders. First-line treatments for PTSD, particularly Prolonged Exposure Therapy (PE), are effective in treating PTSD among those with a SUD. While PE is one of the most effective treatment options for PTSD among those with PTSD+SUD, effects are smaller and dropout is higher than among people with PTSD without a SUD. A promising way to enhance outcomes is to offer PE in a massed format (M-PE; i.e., multiple sessions per week instead of once weekly).
M-PE has been shown to be effective in improving PTSD symptoms and substantially reducing dropout in outpatient care. Preliminary findings suggest M-PE delivered concurrent to intensive SUD programming is a promising strategy that warrants further study. Evaluating the effectiveness of M-PE delivery in of SUD IOP program in improving PTSD and other mental health outcomes is the necessary next step in this critical research.
The mixed-method two-group Hybrid Type I effectiveness-implementation randomized clinical trial (RCT) aims to determine the effectiveness of M-PE delivery in SUD IOP in reducing dropout rates and improving outcomes as compared to trauma treatment as usual (TAU).
The specific aims are to 1) Compare the effectiveness of M-PE to trauma TAU in IOP SUD treatment in impacting PTSD symptoms and Percent days use of primary substance; 2) Explore differences in treatment arms on patient-centered outcomes, including: a) days use of other (non-primary) substances, b) depressive symptoms, c) functioning, c) quality of life (QoL), e) suicidal ideation, and f) participant satisfaction; 3) Examine gender as a moderator and changes in trauma-related cognitions, cravings, and their temporal association as mediators of change in PTSD and substance use; and 4) Conduct a mixed-method process evaluation to understand patients', providers', and clinical stakeholders' experiences with M-PE, explore barriers and facilitators to integrating M-PE into IOP SUD treatment, and identify strategies for widespread implementation.
Participants will include 168 male and female patients with any trauma type who are participating in IOP SUD program at Gateway Community Services, Inc. Assessments will occur at baseline, and will continue for the duration of treatment, at end-of-treatment, 1-month posttreatment, 3-months posttreatment, and 6-months posttreatment. We will conduct a mixed-method, multi-stakeholder process evaluation with patients, providers, and clinical leaders.
- Conditions
- Posttraumatic Stress Disorder (PTSD), Substance Use Disorders (SUD), Comorbidity, Trauma and Stressor Related Disorders
- Being tested
- Massed Prolonged Exposure Therapy (M-PE), Standard outpatient SUD care
- Keywords
- Posttraumatic Stress Disorder (PTSD), Substance Use Disorder (SUD), PTSD/SUD Comorbidity, Prolonged Exposure Therapy (PE), Massed Prolonged Exposure (M-PE), Randomized Clinical Trial (RCT), Treatment as Usual (TAU), Integrated PTSD and SUD Treatment, Implementation Science, Trauma-Focused Treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders, Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massed Prolonged Exposure Therapy (M-PE)Behavioural
Also called M-PE
Massed Prolonged Exposure (M-PE) is a trauma-focused, evidence-based behavioral intervention for posttraumatic stress disorder (PTSD). It is delivered over a compressed timeline (e.g., 10 sessions over 2-4 weeks) as opposed to weekly sessions over 3-4 months. This format has been shown to accelerate PTSD symptom reduction and reduce treatment dropout. In this study, M-PE will be delivered concurrently with an Intensive Outpatient Program (IOP) for substance use disorder (SUD) at Gateway Community Services. Sessions will be led by trained clinicians using a standardized PE protocol, with treatment including imaginal exposure, in vivo exposure, and processing.
Standard outpatient SUD careBehavioural
Also called Usual Care Condition
Patients randomized to usual care will receive standard intensive outpatient SUD treatment.
- Resilience group (weekly)
- Peer support
- Individual therapy from a variety of modalities
| Study group | Role | What they receive |
|---|---|---|
| Massed Prolonged Exposure (M-PE) + Intensive Outpatient Program (IOP) | Experimental | Participants randomized to this arm will receive Massed Prolonged Exposure (M-PE) therapy, a gold-standard treatment for PTSD delivered multiple times per week over 2-4 weeks. M-PE will be integrated into the standard Intensive Outpatient Program (IOP) for substance use disorder (SUD) at Gateway Community Services, Inc. This arm is designed to evaluate the effectiveness of delivering M-PE concurrently with SUD treatment in improving PTSD symptoms, reducing substance use, and improving patient-centered outcomes. Receives: Behavioral: Massed Prolonged Exposure Therapy (M-PE) |
| Trauma Treatment as Usual (TAU) - IOP with Trauma Skills Group | Active comparator | Participants randomized to this arm will receive the standard Intensive Outpatient Program (IOP) for substance use disorder (SUD), which includes a weekly trauma skills group as part of usual care. This comparator arm allows for evaluation of whether M-PE enhances outcomes beyond those achieved through trauma-informed IOP care. Receives: Behavioral: Standard outpatient SUD care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity
Measured: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up
Time Line Follow back (TLFB)
Measures percent days of alcohol or other drug use, score range 0-100%, higher scores indicate greater percent days of use
Measured: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up
Secondary outcomes (3)
Patient Health Questionnaire-9 (PHQ-9)
Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity
Measured: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up
Brief Psychosocial Functioning Inventory (B-IPF)
Measures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment
Measured: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up
Brief Substance Craving Scale (BSCS)
Assesses craving severity for a primary and, if applicable, secondary substance over the past 24 hours. Includes items on intensity, frequency, duration, and number of craving episodes. Higher scores reflect greater craving.
Measured: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start2 Sep 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group randomized controlled trial. Participants will be randomly assigned to receive either (1) Massed Prolonged Exposure (M-PE) therapy integrated within Intensive Outpatient (IOP) Substance Use Disorder (SUD) treatment or (2) Treatment as Usual (TAU) in IOP SUD care, which includes a weekly trauma skills group. The goal is to evaluate the effectiveness of M-PE in improving PTSD and substance use outcomes compared to standard IOP programming.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, San Diego, University of Minnesota
- Responsible party
- Principal investigator, Denise Aimee Hien, Rutgers, The State University of New Jersey
- Investigators
- Sonya Norman Professor Of Clinical, Psychiatry, Ph.D, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968832
- Sponsor's protocol ID
- Pro2024002340
- Other IDs
- 1R01MH132720-01A1
- Acronym
- PROJECT COMET
- Status last verified
- Oct 2025
- First submitted
- 28 Apr 2025
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share individual participant data (IPD) that underlie the results reported in the study, following de-identification and in compliance with IRB and data use agreements. A data dictionary will also be provided to allow for accurate interpretation of variables and data structure. Data will be made available to qualified researchers upon request, following approval of a data use agreement and verification of appropriate data security measures.
Publications
Curto S, Bulgin T, Gette JA, Swarbrick M, Gonnella A, Hien D, Norman SB, Kehle-Forbes SM. Implementing Prolonged Exposure Therapy in a Community Substance Use Treatment Program: A Qualitative Study. Drug Alcohol Rev. 2026 Sep;45(6):e70239. doi: 10.1111/dar.70239.
PubMed 42648713
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project COMET: Hybrid Effectiveness-Implementation Trial of Massed PTSD Treatment in a Community Substance Use Program
- ClinicalTrials.gov ID
- NCT06968832
- Acronym / sponsor ID
- PROJECT COMET / Pro2024002340
- Conditions
- Posttraumatic Stress Disorder (PTSD), Substance Use Disorders (SUD), Comorbidity, Trauma and Stressor Related Disorders
- Keywords
- Posttraumatic Stress Disorder (PTSD), Substance Use Disorder (SUD), PTSD/SUD Comorbidity, Prolonged Exposure Therapy (PE), Massed Prolonged Exposure (M-PE), Randomized Clinical Trial (RCT), Treatment as Usual (TAU), Integrated PTSD and SUD Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, San Diego, University of Minnesota
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if Massed Prolonged Exposure Therapy (M-PE) can improve PTSD symptoms and reduce substance use in adults receiving intensive outpatient (IOP) treatment for substance use disorder (SUD). The main questions it aims to answer are:
- Does M-PE reduce PTSD symptoms more effectively than trauma treatment as usual (TAU)?
- Does M-PE reduce the number of days participants use substances?
- How do patient-centered outcomes (such as depression, suicidal thoughts, and quality of life) differ between M-PE and trauma TAU?
- Researchers will compare M-PE to treatment as usual to see if M-PE leads to better mental health and substance use outcomes and lower dropout rates.
Participants will:
- Attend multiple therapy sessions per week (M-PE) or receive usual care
- Complete assessments at baseline, during treatment, end-of-treatment, 1-month, 3-month, and 6-month follow-up
- Share feedback through surveys and interviews about their experience in the program
Detailed description
Posttraumatic stress disorder (PTSD) and substance use disorder (SUD) often co-occur. PTSD+SUD comorbidity is associated with more severe PTSD, worse treatment outcomes for substance use, greater suicide risk and worse functioning than having one of these disorders. First-line treatments for PTSD, particularly Prolonged Exposure Therapy (PE), are effective in treating PTSD among those with a SUD. While PE is one of the most effective treatment options for PTSD among those with PTSD+SUD, effects are smaller and dropout is higher than among people with PTSD without a SUD. A promising way to enhance outcomes is to offer PE in a massed format (M-PE; i.e., multiple sessions per week instead of once weekly).
M-PE has been shown to be effective in improving PTSD symptoms and substantially reducing dropout in outpatient care. Preliminary findings suggest M-PE delivered concurrent to intensive SUD programming is a promising strategy that warrants further study. Evaluating the effectiveness of M-PE delivery in of SUD IOP program in improving PTSD and other mental health outcomes is the necessary next step in this critical research.
The mixed-method two-group Hybrid Type I effectiveness-implementation randomized clinical trial (RCT) aims to determine the effectiveness of M-PE delivery in SUD IOP in reducing dropout rates and improving outcomes as compared to trauma treatment as usual (TAU).
The specific aims are to 1) Compare the effectiveness of M-PE to trauma TAU in IOP SUD treatment in impacting PTSD symptoms and Percent days use of primary substance; 2) Explore differences in treatment arms on patient-centered outcomes, including: a) days use of other (non-primary) substances, b) depressive symptoms, c) functioning, c) quality of life (QoL), e) suicidal ideation, and f) participant satisfaction; 3) Examine gender as a moderator and changes in trauma-related cognitions, cravings, and their temporal association as mediators of change in PTSD and substance use; and 4) Conduct a mixed-method process evaluation to understand patients', providers', and clinical stakeholders' experiences with M-PE, explore barriers and facilitators to integrating M-PE into IOP SUD treatment, and identify strategies for widespread implementation.
Participants will include 168 male and female patients with any trauma type who are participating in IOP SUD program at Gateway Community Services, Inc. Assessments will occur at baseline, and will continue for the duration of treatment, at end-of-treatment, 1-month posttreatment, 3-months posttreatment, and 6-months posttreatment. We will conduct a mixed-method, multi-stakeholder process evaluation with patients, providers, and clinical leaders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group randomized controlled trial. Participants will be randomly assigned to receive either (1) Massed Prolonged Exposure (M-PE) therapy integrated within Intensive Outpatient (IOP) Substance Use Disorder (SUD) treatment or (2) Treatment as Usual (TAU) in IOP SUD care, which includes a weekly trauma skills group. The goal is to evaluate the effectiveness of M-PE in improving PTSD and substance use outcomes compared to standard IOP programming.
| Arm | Type | Receives |
|---|---|---|
| Massed Prolonged Exposure (M-PE) + Intensive Outpatient Program (IOP) | Experimental | Behavioral: Massed Prolonged Exposure Therapy (M-PE)Participants randomized to this arm will receive Massed Prolonged Exposure (M-PE) therapy, a gold-standard treatment for PTSD delivered multiple times per week over 2-4 weeks. M-PE will be integrated into the standard Intensive Outpatient Program (IOP) for substance use disorder (SUD) at Gateway Community Services, Inc. This arm is designed to evaluate the effectiveness of delivering M-PE concurrently with SUD treatment in improving PTSD symptoms, reducing substance use, and improving patient-centered outcomes. |
| Trauma Treatment as Usual (TAU) - IOP with Trauma Skills Group | Active comparator | Behavioral: Standard outpatient SUD careParticipants randomized to this arm will receive the standard Intensive Outpatient Program (IOP) for substance use disorder (SUD), which includes a weekly trauma skills group as part of usual care. This comparator arm allows for evaluation of whether M-PE enhances outcomes beyond those achieved through trauma-informed IOP care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18+
- Enrolled in SUD treatment at Gateway Community Services
- Meet DSM-5 criteria for a SUD (Tobacco Use Disorder alone not sufficient for inclusion)
- Meet DSM-5 criteria for PTSD
- Able to give informed consent
Key exclusion criteria (3 listed)
- severe cognitive impairment
- current suicidal or homicidal intent requiring immediate treatment
- current unstable psychotic or manic symptoms not attributable to SUD
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 |
|---|---|---|
| Massed Prolonged Exposure Therapy (M-PE)Also: M-PEMassed Prolonged Exposure (M-PE) is a trauma-focused, evidence-based behavioral intervention for posttraumatic stress disorder (PTSD). It is delivered over a compressed timeline (e.g., 10 sessions over 2-4 weeks) as opposed to weekly sessions over 3-4 months. This format has been shown to accelerate PTSD symptom reduction and reduce treatment dropout. In this study, M-PE will be delivered concurrently with an Intensive Outpatient Program (IOP) for substance use disorder (SUD) at Gateway Community Services. Sessions will be led by trained clinicians using a standardized PE protocol, with treatment including imaginal exposure, in vivo exposure, and processing. | Behavioural | Massed Prolonged Exposure (M-PE) + Intensive Outpatient Program (IOP) |
| Standard outpatient SUD careAlso: Usual Care ConditionPatients randomized to usual care will receive standard intensive outpatient SUD treatment. * Resilience group (weekly) * Peer support * Individual therapy from a variety of modalities | Behavioural | Trauma Treatment as Usual (TAU) - IOP with Trauma Skills Group |
Primary outcome
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up
Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity
Time Line Follow back (TLFB)
Time frame: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up
Measures percent days of alcohol or other drug use, score range 0-100%, higher scores indicate greater percent days of use
3 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up
Brief Psychosocial Functioning Inventory (B-IPF)
Time frame: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up
Brief Substance Craving Scale (BSCS)
Time frame: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Derived from this study: PubMed 42648713Curto S, Bulgin T, Gette JA, Swarbrick M, Gonnella A, Hien D, Norman SB, Kehle-Forbes SM. Implementing Prolonged Exposure Therapy in a Community Substance Use Treatment Program: A Qualitative Study. Drug Alcohol Rev. 2026 Sep;45(6):e70239. doi: 10.1111/dar.70239.
- Individual participant dataSharing planned: Yes. We plan to share individual participant data (IPD) that underlie the results reported in the study, following de-identification and in compliance with IRB and data use agreements. A data dictionary will also be provided to allow for accurate interpretation of variables and data structure. Data will be made available to qualified researchers upon request, following approval of a data use agreement and verification of appropriate data security measures.
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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.
Denise Hien Helen E. Chaney Endowed Chair in Alcohol Studies, Ph.D contact
Sonya Norman Professor Of Clinical, Psychiatry, Ph.D principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massed Prolonged Exposure Therapy (M-PE) and Standard outpatient SUD care in people with Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders (SUD), run by Rutgers, The State University of New Jersey 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Oct 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denise Hien Helen E. Chaney Endowed Chair in Alcohol Studies, Ph.D (848-445-0749, denise.hien@smithers.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: Baseline; End of Treatment (6 weeks post-randomization); 1-month (10 weeks), 3-month (18 weeks), and 6-month (30 weeks) post-randomization follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06968832, which also lists 1 linked publication.
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 27 Oct 2025; AzTrials last refreshed its copy on 26 Oct 2026.