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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapted STAIR-NT Intervention | Experimental |
| |
| Treatment as Usual (TAU) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT) | Behavioral | Adapted version of evidence-based behavioral PTSD intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Proportion of Eligible Participants who Enroll | .Proportion of all eligible persons who enroll. Assessed using count data of individuals consented. | Baseline |
| Number of Intervention Sessions Completed | 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. | 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. | Month 3 |
| Number of Days of Co-Use of Cocaine and Illicit Opioids | Measured using the Addiction Severity Index (ASI) questionnaire. | Month 3 |
| Number of Substances Used based on ASI Self-Report |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Bunting | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Tallahassee | Florida | 32306 | United States | ||
| START Treatment and Recovery Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39627789 | Derived | 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. |
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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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. The data will be stored in a data repository.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 7, 2025 | Mar 10, 2026 |
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The data analyst is blinded to participant arm.
| Treatment as Usual | Behavioral | Treatment as usual. |
|
Measured using the Addiction Severity Index (ASI) questionnaire, a self-report assessment to gauge the severity of a person's substance abuse. |
| Month 3 |
| Number of Substances Used based on Urine Drug Screen | Month 3 |
| Number of Substances Used based on Chart Abstraction of Toxicology Results | 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. | 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. | 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. | Month 3 |
| Brooklyn |
| New York |
| 11238 |
| United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D062525 | Narrative Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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