NCT06001437

Brief Summary

The aim of this study is to describe outcome of people with opioid use disorder over the long-term by collecting monthly and yearly data on their recovery. Adults with opioid use disorder who participate will complete surveys monthly online and once per year by phone about their substance use, mental health, treatment involvement and functioning. The goal of this study is to better understand how people with opioid use disorder recover over time to improve intervention for this group.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

September 2, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

August 14, 2023

Last Update Submit

May 15, 2026

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

  • Opioid Use

    Count of months of opioid use.

    12 months

  • Engagement in Treatment

    Count of months engaged in treatment for opioid use disorder

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with opioid use disorder who have previously participated in one of two applicable opioid use disorder clinical trials in the NIDA Clinical Trials Network.

You may qualify if:

  • Be an enrolled participant in one of two applicable clinical trials and be no longer than 24 months after the final expected assessment for that trial.
  • Be willing and able to provide locator information for survey distribution (mobile number and/or email address).
  • Be willing to allow the linkage of prior clinical trial study data to the current study record.

You may not qualify if:

  • Unable to understand or communicate to complete consent or study assessments.
  • Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.
  • Other factors that would cause harm or increased risk to the participant or close contacts or preclude the participant's full adherence with or completion of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 14, 2023

First Posted

August 21, 2023

Study Start

September 2, 2023

Primary Completion

July 1, 2026

Study Completion

August 1, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations

US(1)