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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 6 months
Awards & highlights
Study Summary
This trial will help us address the opioid crisis by helping people with OUD and their families get the help they need. It will also provide insight into how digital solutions can help combat opioid use.
Eligible Conditions
- Substance Use Disorders
- Family Health
- Community Reinforcement and Family Training (CRFT)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
CRAFT Knowledge: CRAFT Knowledge Scale
CSO Health and Wellbeing: Profile of Mood State (POMS) - Short Form
CSO Health and Wellbeing: SF-12 Physical Health Subscale
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CRAFTExperimental Treatment1 Intervention
Participants assigned to CRAFT will have access to a 12-module on-line CRAFT intervention and asked to complete one module weekly for 12 weeks. Modules introduce CRAFT concepts and provide workbooks to assist participants in learning and applying the concepts. The modules that are unlocked weekly include: 1) Introduction to CRAFT; 2) Communication Training; 3) Functional Analysis of Drug Using; 4) Positive Reinforcement; 5) Problem-solving; 6) Withdrawing Reinforcement; 7) Allowing Natural Consequences; 8) Life Enrichment; 9) Suggesting Treatment; 10) Recovery and Relapse; 11) Relationship; and 12) Recap of Skills. Two additional modules (domestic violence and opioid overdose precautions) are available at any time. CRAFT participants also attend weekly 60-minute online group sessions facilitated by a CRAFT-certified coach. During weekly group or individual sessions concepts are briefly reviewed, questions are answered, and skills are practiced through role-plays of common situations.
Group II: PEERActive Control1 Intervention
Participants assigned to the PEER condition will participate in an online peer support forum with other CSOs. Members of the forum post questions or comments to weekly peer-led discussions and receive responses and feedback from other CSO forum members. Members typically express concerns regarding their IP's wellbeing and ask other members to share any strategies they have employed when dealing with their IPs.
Interactions typically, are based either in 12-Step strategies members have learned (usually through Al-Anon or Nar-Anon Family Groups or Family Training Workshops provided by treatment programs). A staff member from We The Village monitors forum interactions to ensure members are interacting respectfully.
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Who is running the clinical trial?
We The Village, Inc.Lead Sponsor
2 Previous Clinical Trials
92 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,421 Total Patients Enrolled
Public Health Management CorporationOTHER
16 Previous Clinical Trials
5,122 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are worried about someone close to you who is taking opioids.You are not able to understand the form that explains the study and gives permission to participate.You have already taken part in an earlier We The Village pilot study.You have a history of drug addiction or dependency and have not been in recovery for at least two years.You are someone who is worried about a family member or loved one who has a serious illness.You do not have an addiction to drugs or alcohol.
Research Study Groups:
This trial has the following groups:- Group 1: CRAFT
- Group 2: PEER
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 enrollment opened for this research project?
"According to clinicaltrials.gov, this medical experiment is accepting participants and has gone through multiple updates since its initial launch on November 29th 2022."
Answered by AI
How many individuals can partake in this experiment at one time?
"Indeed, the clinicaltrials.gov website states that this research is actively recruiting patients. The study was made available on November 29th 2022 and has been updated as recently as December 18 of the same year. This trial requires 212 volunteers to be enrolled across one medical location."
Answered by AI
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