Recruiting

Observational Study

Sponsor:

University of Massachusetts, Worcester

Code:

NCT05138614

Conditions

Opioid Use Disorder

Mental Health Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medication for Opioid Use Disorder

MISSION Critical Time Intervention

MISSION Peer Support

MISSION Dual Recovery Therapy

Study Details

Brief summary:

This 4-year study will randomize 1,000 people with co-occurring opioid use and mental health disorders (COD) at medication for opioid use disorder (MOUD) clinics to evaluate the effectiveness of MISSION, a multi-component team approach, or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or its components for improving outcomes. We expect that individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: engagement, substance use, and mental health.

Conditions

Opioid Use Disorder

Mental Health Disorder

Study ID

NCT05138614

Start date

Mar 11, 2022

Status verified date

Jun, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Are 18 years-old and older;
  • Are fluent in English or Spanish;
  • Have OUD who (a) are newly admitted into the program with OUD; or (b) who have been active in the program for the treatment of OUD with medications like buprenorphine or naltrexone, but experienced a recent relapse with any substance (e.g., alcohol, cocaine, opioids, or benzodiazepines). This second group is necessary to include because patients who may have been stable for a long period of time may have a relapse and need intensive treatment to help them regain their abstinence and facilitate the path towards recovery. Thus, by taking those newly enrolled and those who were stable on MOUD but had a recent relapse, the second group is clinically similar to the first group and the intervention will be meaningful.;
  • Able to provide consent;
  • Potentially have a concurrent substance use disorder in addition to opioids; and
  • Have a co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and/or schizophrenia, and those who are stable on buprenorphine or naltrexone but have recurrence or worsening at any time of symptoms of any co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and/or schizophrenia, even if the patient has not relapsed. Instability is defined in two ways in the study: (a) a substance use relapse; and (b) recurrence to symptom exacerbation in regard to a subject's mental health disorder(s). If subjects do not meet criteria for "a" (i.e., not having a substance use relapse), but they do meet criteria for "b" (i.e., they do in fact have worsening of mental health symptoms), they are then defined as unstable, and will meet study inclusion criteria.

Exclusion Criteria:

  • Are not fluent in English or Spanish;
  • Are acutely psychotic, acutely suicidal with a plan, or homicidal;
  • Are incompetent and unable to provide informed consent; and
  • Have concurrent severe alcohol use disorder or high dose benzodiazepine needing detoxification. This exclusion factor is based on DSM-5 criteria, and those who are currently drinking or with a history of severe alcohol withdrawal (i.e., alcohol related seizures, and delirium tremens) will also be excluded. High dose benzodiazepine is defined as using Lorazepam equivalent of > 10 mg/day; Diazepam > 100 mg/day; Clonazepam 5 mg/ day; Alprazolam 5 mg/day.

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Full MISSION

CTI + DRT + PS + MOUD

experimental: CTI & DRT

CTI + DRT + MOUD

experimental: CTI & PS

CTI + PS + MOUD

experimental: DRT & PS

DRT + PS + MOUD

other: MOUD only

MOUD

Interventions

Medication for Opioid Use Disorder

medication management

MISSION Critical Time Intervention

offering intensive community-based services that decrease in intensity over time

MISSION Peer Support

including 11 recovery-oriented sessions from someone with lived experience of co-occurring disorders

MISSION Dual Recovery Therapy

comprised of 13 structured co-occurring disorders treatment sessions

Primary outcome measure

  • Engagement in treatment [ Time Frame: 6 months ]
  • Engagement in medication for opioid use disorder (MOUD) [ Time Frame: 6 months ]
  • Engagement in outreach and linkage sessions [ Time Frame: 6 months ]
  • Self-report opioid use and other substance use [ Time Frame: Baseline ]
  • Self-report opioid use and other substance use [ Time Frame: 3 months ]
  • Self-report opioid use and other substance use [ Time Frame: 6 months ]
  • Self-report opioid use and other substance use [ Time Frame: 9 months ]
  • Self-report opioid use and other substance use [ Time Frame: 12 months ]
  • Opioid use and other substance use (drug screen) [ Time Frame: 3 months ]
  • Opioid use and other substance use (drug screen) [ Time Frame: 6 months ]
  • Mental health functioning [ Time Frame: Baseline ]
  • Mental health functioning [ Time Frame: 3 months ]
  • Mental health functioning [ Time Frame: 6 months ]
  • Mental health functioning [ Time Frame: 9 months ]
  • Mental health functioning [ Time Frame: 12 months ]
  • PTSD symptoms [ Time Frame: Baseline ]
  • PTSD symptoms [ Time Frame: 3 months ]
  • PTSD symptoms [ Time Frame: 6 months ]
  • PTSD symptoms [ Time Frame: 9 months ]
  • PTSD symptoms [ Time Frame: 12 months ]
  • Mental health impairment [ Time Frame: Baseline ]
  • Mental health impairment [ Time Frame: 3 months ]
  • Mental health impairment [ Time Frame: 6 months ]
  • Mental health impairment [ Time Frame: 9 months ]
  • Mental health impairment [ Time Frame: 12 months ]
  • Psychiatric severity [ Time Frame: Baseline ]
  • Health functioning [ Time Frame: Baseline ]
  • Health functioning [ Time Frame: 3 months ]
  • Health functioning [ Time Frame: 6 months ]
  • Health functioning [ Time Frame: 9 months ]
  • Health functioning [ Time Frame: 12 months ]
  • Motivation for treatment [ Time Frame: Baseline ]
  • Motivation for treatment [ Time Frame: 3 months ]
  • Motivation for treatment [ Time Frame: 6 months ]
  • Motivation for treatment [ Time Frame: 9 months ]
  • Motivation for treatment [ Time Frame: 12 months ]
  • Suicide Severity [ Time Frame: Baseline ]
  • Suicide Severity [ Time Frame: 3 months ]
  • Suicide Severity [ Time Frame: 6 months ]
  • Suicide Severity [ Time Frame: 9 months ]
  • Suicide Severity [ Time Frame: 12 months ]
  • Therapeutic alliance [ Time Frame: Baseline ]
  • Therapeutic alliance [ Time Frame: 3 months ]
  • Therapeutic alliance [ Time Frame: 6 months ]
  • Therapeutic alliance [ Time Frame: 9 months ]
  • Therapeutic alliance [ Time Frame: 12 months ]
  • Recovery Capital [ Time Frame: Baseline ]
  • Recovery Capital [ Time Frame: 3 months ]
  • Recovery Capital [ Time Frame: 6 months ]
  • Recovery Capital [ Time Frame: 9 months ]
  • Recovery Capital [ Time Frame: 12 months ]
  • Chronic pain [ Time Frame: Baseline ]
  • Chronic pain [ Time Frame: 3 months ]
  • Chronic pain [ Time Frame: 6 months ]
  • Chronic pain [ Time Frame: 9 months ]
  • Chronic pain [ Time Frame: 12 months ]
  • Medication Adherence [ Time Frame: 3 months ]
  • Medication Adherence [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

David Smelson, PsyD

508-713-5420David.Smelson@umassmed.edu

Abigail Helm, PhD

413-313-2806Abigail.Helm@umassmed.edu

Locations

Behavioral Health Network

Recruiting

Holyoke, Massachusetts, United States, 01040

Behavioral Health Network

Recruiting

Orange, Massachusetts, United States, 01364

Contacts

Calla Harrington

calla.harrington@bhninc.org

Behavioral Health Network

Recruiting

Springfield, Massachusetts, United States, 01104

Contacts

Herschelle Reaves

herschelle.reaves@bhninc.org

UMass Chan Road to Care Clinic

Recruiting

Worcester, Massachusetts, United States, 01601

Contacts

Brittany Chapman

brittany.chapman@umassmed.edu

SaVida Health

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Shelley Modzeleski

s.modzeleski@savidahealth.com

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • opioid use disorder
  • mental health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-06-04.