Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

NYU Langone Health

Status: Enrolling

Conditions: Posttraumatic Stress Disorder; Polysubstance Abuse

Treatments: Behavioral: Treatment as Usual; Behavioral: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06307340

22-01058

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Adapted STAIR-NT Intervention

Experimental group

Treatment:

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

Treatment as Usual (TAU)

Active Comparator group

Treatment:

Behavioral: Treatment as Usual