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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18-65 years of age
Female (biological sex at birth)
Must not have
Major medical illness or Central Nervous System disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of six months after release from incarceration
Awards & highlights
No Placebo-Only Group
Summary
This trial will support the development and evaluation of a mindfulness intervention for female prison inmates that will target key neuropsychological vulnerabilities that are associated with relapse and recidivism.
Who is the study for?
This trial is for English-speaking female inmates aged 18-65 with alcohol use disorder, who are not due to be released within the next three months. They must have at least a 5th-grade reading level. Those with metal in their body, low IQ scores, psychotic disorders, dementia or cognitive disabilities, major illnesses or CNS diseases, and severe hearing or vision problems cannot join.
What is being tested?
The study is evaluating a mindfulness program designed to address neuropsychological factors linked to relapse and criminal behavior in women prisoners with alcohol abuse issues. The goal is to reduce the cycle of drinking and re-offending.
What are the potential side effects?
Mindfulness interventions typically do not cause physical side effects but can sometimes lead to increased emotional sensitivity or discomfort as participants become more aware of their thoughts and feelings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I am biologically female.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a major illness or brain disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks, 8 weeks, and after release from incarceration (every 3 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks, 8 weeks, and after release from incarceration (every 3 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline alcohol craving
Change from baseline daily alcohol consumption
Change from baseline temptation to drink alcohol
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Relapse PreventionExperimental Treatment1 Intervention
Group II: MindfulnessExperimental Treatment1 Intervention
Mindfulness
Group III: Treatment as UsualActive Control1 Intervention
Group IV: Waitlist ControlActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness
2014
Completed Phase 2
~3200
Relapse Prevention
2009
Completed Phase 3
~400
Find a Location
Who is running the clinical trial?
The Mind Research NetworkLead Sponsor
26 Previous Clinical Trials
1,862 Total Patients Enrolled
1 Trials studying Criminal Behavior
334 Patients Enrolled for Criminal Behavior
University of Wisconsin, MadisonOTHER
1,231 Previous Clinical Trials
3,199,405 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of dementia or other conditions that affect your ability to think and remember.Your IQ score is below 70.I am between 18 and 65 years old.I am biologically female.You cannot have an MRI scan because you have metal in your body.You should be able to read and understand texts at least at a 5th grade level.You have a problem with drinking too much alcohol.You have hearing or vision problems that cannot be corrected.You currently have a mental illness that includes active psychotic symptoms.I do not have a major illness or brain disease.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness
- Group 2: Relapse Prevention
- Group 3: Treatment as Usual
- Group 4: Waitlist Control
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.
Criminal Behavior Patient Testimony for trial: Trial Name: NCT03883646 — N/A
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