START NOW in the Treatment of Opioid Addicted Individuals

NCT05552040 | Completed

• 1 other identifier: IRB-20-1064
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation involves a partially randomized clinical trial examining the effectiveness of combining buprenorphine/naloxone MAT with START NOW, a skills-based psychosocial intervention modified specifically for the ambulatory substance use disorder (SUD) patient population. START NOW is an integrated evidence-informed model based on an adapted form of dialectical behavior therapy (DBT), a type of cognitive behavior therapy (CBT) with promising indications for treating SUD as it targets impulsive and self-destructive behaviors. Furthermore, START NOW combines CBT, the most widely used evidence-based psychosocial intervention for treating mental disorders, with motivational interviewing, which in clinical trials has been shown to be an effective technique for engaging patients with SUD. In addition to tracking clinical outcomes such as abstinence rates through weekly urine drug screens, this investigation will use: clinician assessments of disease severity, researcher-evaluated tests of delayed discounting (DD) and demand tasks, and self-report surveys assessing impulsivity, aggression, interpersonal skills, and other measures to capture the patients' sense of progress in treatment in regards to their substance use, health, lifestyle, and community. By using DD and functional magnetic resonance imaging (fMRI), the identification of the neural correlates of START NOW treatment response will begin to elucidate the mechanisms of START NOW's effects and more. This investigation's outcome measures may not only compare the effectiveness between START NOW and treatment-as-usual (TAU), but also provide a more realistic, holistic view of patients and their well-being throughout the recovery process. DD will be performed by both START NOW group members and TAU group members at their group therapy meetings as per protocol. Additionally, START NOW group members randomized and consented to have an fMRI will also perform DD before the scan is initiated.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (4)

• Retention in treatment by group attendance

  Translates to # groups attended (max 32)

  32 -52 weeks

• Retention in treatment by time in study

  Weeks from consent to last group attended

  32 -52 weeks

• Intensity of treatment

  total number-of-groups-attended divided by number of weeks from consent to last group attended

  32 -52 weeks

• Drug use based on drug screen results

  Drug use during trial period was determined by drug screens, which were collected weekly or monthly based on clinician preference throughout the entire 8-month investigation for each participant

  32-52 weeks

Study Arms (2)

START NOW Group

EXPERIMENTAL

START NOW is an evidence-informed psychotherapy composed of a total of 32-skills-based-sessions, originally designed for inmates in correctional systems. A previous study of incarcerated individuals found that for each additional session of START NOW completed, a 5% reduction in the incident rate of disciplinary reports was noted.10 In fact, individuals with a higher overall security risk score also had a greater reduction in the number of disciplinary reports with more sessions attended, suggesting that START NOW is an effective behavioral intervention for those who need it most. A follow-up study on these same participants concluded that START NOW appears to have a beneficial clinical effect with each session completed being associated with a 5% decrease in subsequent psychiatric hospital days.

Behavioral: START NOW Group

Treatment-as-Usual (TAU) Group

ACTIVE COMPARATOR

TAU groups are weekly sessions required in an OBOT clinic and focus primarily on supportive therapeutic techniques.

Behavioral: START NOW Group

Interventions

START NOW Group BEHAVIORAL

START NOW psychotherapy is a CBT, DBT and skills-based intervention

START NOW Group; Treatment-as-Usual (TAU) Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 18 years or older with OUD diagnosis participating in OBOT

You may not qualify if:

• Imminent suicide risk at investigator discretion
• Unable to commit to participation in the planned 32 session regimen
• Unmanaged psychiatric illness that would interfere in study participation, as determined by investigator
• Pregnant patients with OUD \[for the imaging study ONLY\]

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Robert L Trestman, PhD, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistical analysis completed by Virginia Tech Department of Statistics faculty and graduate students who were all blinded with respect to group assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Psychiatry and Behavioral Medicine

Model Details: START NOW group psychotherapy versus Treatment-as-Usual group psychotherapy in OUD individuals in an OBOT program

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 23, 2022
• Study Start: October 4, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)