Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-14

Study Completion Date

2026-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Polysubstance Abuse Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

The data analyst is blinded to participant arm.

Study Groups

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Adapted STAIR-NT Intervention

Group Type EXPERIMENTAL

Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)

Intervention Type BEHAVIORAL

Adapted version of evidence-based behavioral PTSD intervention.

Treatment as Usual (TAU)

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type BEHAVIORAL

Treatment as usual.

Interventions

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Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)

Adapted version of evidence-based behavioral PTSD intervention.

Intervention Type BEHAVIORAL

Treatment as Usual

Treatment as usual.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No