Polysubstance Abuse, Posttraumatic Stress Disorder
Conditions
Brief 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 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.
Interventions
BEHAVIORALSkills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)
Adapted version of evidence-based behavioral PTSD intervention.
BEHAVIORALTreatment as Usual
Treatment as usual.
Sponsors
NYU Langone Health
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The data analyst is blinded to participant arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eligible Participants | 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 | Baseline | .Proportion of all eligible persons who enroll. Assessed using count data of individuals consented. |
| Number of Intervention Sessions Completed | Up to Month 3 | — |
| Clinician-Rated Feasibility of Intervention Measure (FIM) Score | 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 | 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 | Month 3 | Measured using the Addiction Severity Index (ASI) questionnaire. |
| Number of Substances Used based on ASI Self-Report | 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 | Month 3 | — |
| Number of Substances Used based on Chart Abstraction of Toxicology Results | Month 3 | — |
| PTSD Checklist for DSM-5 (PCL-5) Score | 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 | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmanda Bunting
NYU Langone Health
Outcome results
None listed