Polysubstance AbuseNCT06307340
Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations
A study testing Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT) and Treatment as Usual in people with Polysubstance Abuse and Posttraumatic Stress Disorder, run by NYU Langone Health at 3 sites in United States.
Trial summary
During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polysubstance Abuse, Posttraumatic Stress Disorder
- What is being tested?
- Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT) and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Oct 2024to 30 Sep 2026
- 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
- must be 18 years or older,
- be a patient at the START clinic receiving methadone for treatment of opioid use disorder,
- self-report 10+ days of co-use of cocaine and illicit opioids in the past 30-days,
- meet the criteria for stimulant use disorder (cocaine type; mild, moderate or severe) and a score of 3≥ on the PC-PTSD-5.
Who cannot join
- cognitive impairment that would interfere with their ability to understand study participation as assessed by the researcher,
- does not speak/understand English at a conversational level,
- plans to leave the START clinic in the next 60 days,
- patients who missed methadone doses (inactive) for 30 days or more, or
- having received clinical care from the interventionist(s) in the past 30 days
Trial locations and contacts
3 sites in 1 country.
United States3 sites
START Treatment and Recovery Centers
Brooklyn, New York, 11238
NYU Langone Health
New York, New York, 10016
Florida State University
Tallahassee, Florida, 32306
About this study
During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors.
- Conditions
- Polysubstance Abuse, Posttraumatic Stress Disorder
- Being tested
- Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT), Treatment as Usual
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)Behavioural
Adapted version of evidence-based behavioral PTSD intervention.
Treatment as UsualBehavioural
Treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| Adapted STAIR-NT Intervention | Experimental | Not described Receives: Behavioral: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT) |
| Treatment as Usual (TAU) | Active comparator | Not described Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Eligible Participants
Proportion of persons eligible to enroll in the study of all possible MMT patients approached. Assessed using count data of individuals failing screen.
Measured: Baseline
Proportion of Eligible Participants who Enroll
.Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.
Measured: Baseline
Number of Intervention Sessions Completed
Measured: Up to Month 3
Clinician-Rated Feasibility of Intervention Measure (FIM) Score
4-item, clinician-rated assessment of the feasibility of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated feasibility.
Measured: Month 3
Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score
4-item, clinician-rated assessment of the acceptability of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated acceptability.
Measured: Month 3
Number of Days of Co-Use of Cocaine and Illicit Opioids
Measured using the Addiction Severity Index (ASI) questionnaire.
Measured: Month 3
Number of Substances Used based on ASI Self-Report
Measured using the Addiction Severity Index (ASI) questionnaire, a self-report assessment to gauge the severity of a person's substance abuse.
Measured: Month 3
Number of Substances Used based on Urine Drug Screen
Measured: Month 3
Number of Substances Used based on Chart Abstraction of Toxicology Results
Measured: Month 3
PTSD Checklist for DSM-5 (PCL-5) Score
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Each item is rated on a scale from 0-4. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; higher scores indicate greater severity of PTSD.
Measured: Month 3
Negative Mood Regulation Scale Score
30-item assessment of individuals' beliefs and expectations regarding their ability to regulate their negative mood and emotions. Each item is rated on a 5-point Likert scale ranging from 1 (not at all effective) to 5 (extremely effective). The total score ranges from 30-150; higher scores indicate more effective negative mood regulation.
Measured: Month 3
Inventory of Interpersonal Problems Score
A 127-item, self-report inventory that asks participants to rate a variety of interpersonal problems that may cause distress. The items are divided into two groups: (1) interpersonal inadequacies or inhibitions (78 items), (2) excesses or compulsions (49 items). Participants rate each item on a scale from 0 to 4 on how much difficulty/distress they feel regarding the item. The total score is calculated by adding the item responses; lower scores indicate less difficulty/distress.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start14 Oct 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (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 Polysubstance AbuseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Amanda Bunting, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307340
- Sponsor's protocol ID
- 22-01058
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified quantitative assessment data will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. Data will be stored in a data repository. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Renn T, Griffin B, Kumaravelu V, Ventuneac A, Santacatterina M, Bunting AM. Study protocol for a randomized controlled trial to adapt a posttraumatic stress disorder intervention of patients with opioid-stimulant polysubstance use receiving methadone maintenance treatment. BMC Psychiatry. 2024 Dec 4;24(1):879. doi: 10.1186/s12888-024-06348-0.
PubMed 39627789
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations
- ClinicalTrials.gov ID
- NCT06307340
- Acronym / sponsor ID
- 22-01058
- Conditions
- Polysubstance Abuse, Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 12 Mar 2024 (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.
During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted STAIR-NT Intervention | Experimental | Behavioral: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT) |
| Treatment as Usual (TAU) | Active comparator | Behavioral: Treatment as Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- must be 18 years or older,
- be a patient at the START clinic receiving methadone for treatment of opioid use disorder,
- self-report 10+ days of co-use of cocaine and illicit opioids in the past 30-days,
- meet the criteria for stimulant use disorder (cocaine type; mild, moderate or severe) and a score of 3≥ on the PC-PTSD-5.
Key exclusion criteria (5 listed)
- cognitive impairment that would interfere with their ability to understand study participation as assessed by the researcher,
- does not speak/understand English at a conversational level,
- plans to leave the START clinic in the next 60 days,
- patients who missed methadone doses (inactive) for 30 days or more, or
- having received clinical care from the interventionist(s) in the past 30 days
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 |
|---|---|---|
| Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)Adapted version of evidence-based behavioral PTSD intervention. | Behavioural | Adapted STAIR-NT Intervention |
| Treatment as UsualTreatment as usual. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Proportion of Eligible Participants
Time frame: Baseline
Proportion of persons eligible to enroll in the study of all possible MMT patients approached. Assessed using count data of individuals failing screen.
Proportion of Eligible Participants who Enroll
Time frame: Baseline
.Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.
Number of Intervention Sessions Completed
Time frame: Up to Month 3
Clinician-Rated Feasibility of Intervention Measure (FIM) Score
Time frame: Month 3
4-item, clinician-rated assessment of the feasibility of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated feasibility.
Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score
Time frame: Month 3
4-item, clinician-rated assessment of the acceptability of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated acceptability.
Number of Days of Co-Use of Cocaine and Illicit Opioids
Time frame: Month 3
Measured using the Addiction Severity Index (ASI) questionnaire.
Number of Substances Used based on ASI Self-Report
Time frame: Month 3
Measured using the Addiction Severity Index (ASI) questionnaire, a self-report assessment to gauge the severity of a person's substance abuse.
Number of Substances Used based on Urine Drug Screen
Time frame: Month 3
Number of Substances Used based on Chart Abstraction of Toxicology Results
Time frame: Month 3
PTSD Checklist for DSM-5 (PCL-5) Score
Time frame: Month 3
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Each item is rated on a scale from 0-4. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; higher scores indicate greater severity of PTSD.
Negative Mood Regulation Scale Score
Time frame: Month 3
30-item assessment of individuals' beliefs and expectations regarding their ability to regulate their negative mood and emotions. Each item is rated on a 5-point Likert scale ranging from 1 (not at all effective) to 5 (extremely effective). The total score ranges from 30-150; higher scores indicate more effective negative mood regulation.
Inventory of Interpersonal Problems Score
Time frame: Month 3
A 127-item, self-report inventory that asks participants to rate a variety of interpersonal problems that may cause distress. The items are divided into two groups: (1) interpersonal inadequacies or inhibitions (78 items), (2) excesses or compulsions (49 items). Participants rate each item on a scale from 0 to 4 on how much difficulty/distress they feel regarding the item. The total score is calculated by adding the item responses; lower scores indicate less difficulty/distress.
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 12 Mar 2026.
- Derived from this study: PubMed 39627789Renn T, Griffin B, Kumaravelu V, Ventuneac A, Santacatterina M, Bunting AM. Study protocol for a randomized controlled trial to adapt a posttraumatic stress disorder intervention of patients with opioid-stimulant polysubstance use receiving methadone maintenance treatment. BMC Psychiatry. 2024 Dec 4;24(1):879. doi: 10.1186/s12888-024-06348-0.
- Individual participant dataSharing planned: Yes. Deidentified quantitative assessment data will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. Data will be stored in a data repository. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Amanda Bunting principal investigator
NYU Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT) and Treatment as Usual in people with Polysubstance Abuse and Posttraumatic Stress Disorder, run by NYU Langone Health at 3 sites 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Proportion of Eligible Participants (time frame: Baseline). The study lists 12 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 NCT06307340, 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 12 Mar 2026.