Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to three years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to three years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to three years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Client Satisfaction Questionnaire 8-item (CSQ-8)
Credibility subscale of the Credibility/Expectancy Questionnaire (CEQ)
Expectancy item of the Credibility/Expectancy Questionnaire (CEQ)
+3 moreSecondary outcome measures
Change in buprenorphine appointment attendance
Change in days of opioid use on the Addiction Severity Index-Lite
Change in the Medical Outcomes Study (MOS) Social Support Survey
+2 moreTrial 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
1,611 Previous Clinical Trials
3,305,234 Total Patients Enrolled
Victoria Ameral, PhDPrincipal InvestigatorVA Bedford HealthCare System, Bedford, MA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I started buprenorphine treatment less than 2 weeks ago after not being treated for over 2 months.I do not have any cognitive issues that would prevent me from participating in the study.I have been hospitalized for suicidal thoughts or actions.You are currently using drugs and need to stop using them before participating.I am able to understand and sign the consent form.You are currently experiencing severe mental health symptoms like hallucinations or extreme mood swings.
Research Study Groups:
This trial has the following groups:- Group 1: Open Pilot
- Group 2: Active Condition
- Group 3: Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has recruitment for this experiment opened up to the public yet?
"Evidently, according to clinicaltrials.gov this trial is not presently enrolling patients; the original posting occurred on June 1st 2023 and was last updated July 21st 2022. Nonetheless, there are 291 other medical investigations actively recruiting participants at present."
Answered by AI
What objectives have been established to evaluate the efficacy of this experiment?
"The objectives of this week-long clinical trial are to measure the number of participants that have been recruited. Secondary outcomes include evaluations of quality-of-life (WHOQOL-BREF), days spent using opioids (Addiction Severity Index-Lite) and social functioning according to the Social Adjustment Scale - Self Report, which ranges from 1 to 5 with higher scores indicating greater impairment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger