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Values-Based Intervention for Opioid Use Disorder

N/A
Recruiting
Led By Victoria Ameral, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Cognitive impairment that would interfere with study participation
Suicidality requiring inpatient hospitalization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to three years
Awards & highlights
No Placebo-Only Group

Summary

This trial will help develop a values-based treatment to improve quality of life for Veterans during early treatment for opioid use disorder.

Who is the study for?
This trial is for US Veterans with moderate to severe opioid use disorder who have started buprenorphine treatment in the last 2 weeks after a gap of at least 2 months. Participants must be able to consent and not require hospitalization for suicidality, detoxification for active substance use, or have psychosis, mania, or cognitive impairments that could affect participation.
What is being tested?
The study is testing a new brief values-based intervention aimed at improving life quality by enhancing interpersonal functioning and community integration during early recovery from opioid dependence. It will be compared against the usual treatment methods in a pilot randomized controlled trial involving initially development and feedback phases.
What are the potential side effects?
Since this intervention focuses on psychological support rather than medication, it may not have typical drug side effects. However, discussing personal values can sometimes bring up emotional discomfort or stress.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any cognitive issues that would prevent me from participating in the study.
Select...
I have been hospitalized for suicidal thoughts or actions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to three years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to three years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Client Satisfaction Questionnaire 8-item (CSQ-8)
Credibility subscale of the Credibility/Expectancy Questionnaire (CEQ)
Expectancy item of the Credibility/Expectancy Questionnaire (CEQ)
+3 more
Secondary study objectives
Change in days of opioid use on the Addiction Severity Index-Lite
Change in medication (buprenorphine, methadone, or naltrexone) appointment attendance
Change in the Medical Outcomes Study (MOS) Social Support Survey
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Open PilotExperimental Treatment1 Intervention
In Phase 2, all Veterans will receive the active treatment.
Group II: Active ConditionExperimental Treatment1 Intervention
In Phase 3 (Pilot RCT), half of Veterans will be randomly assigned to the active treatment.
Group III: Treatment as UsualActive Control1 Intervention
In Phase 3 (Pilot RCT), half of Veterans will be randomly assigned to treatment as usual.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,675 Total Patients Enrolled
1 Trials studying Opioid Addiction
42 Patients Enrolled for Opioid Addiction
Victoria Ameral, PhDPrincipal InvestigatorVA Bedford HealthCare System, Bedford, MA

Media Library

Brief, values based intervention for early buprenorphine treatment Clinical Trial Eligibility Overview. Trial Name: NCT05189223 — N/A
Opioid Addiction Research Study Groups: Open Pilot, Active Condition, Treatment as Usual
Opioid Addiction Clinical Trial 2023: Brief, values based intervention for early buprenorphine treatment Highlights & Side Effects. Trial Name: NCT05189223 — N/A
Brief, values based intervention for early buprenorphine treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05189223 — N/A
~33 spots leftby Mar 2027
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