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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment, 12-months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether reducing stress and increasing engagement in positive activities can decrease alcohol use in non-student adults.
Who is the study for?
This trial is for non-student emerging adults aged 18-29 who drink heavily but aren't currently using drugs (except cannabis) or seeking addiction treatment. They must speak English, be able to read at a 9th-grade level, and have had multiple heavy drinking episodes recently.
What is being tested?
The study tests if stress reduction and engaging in positive activities can help reduce alcohol use among young adults. It compares an educational control with substance-free activity sessions, brief alcohol interventions, and relaxation training.
What are the potential side effects?
Since this trial involves behavioral interventions like education and relaxation techniques rather than medication, side effects are minimal but may include discomfort from discussing personal habits or slight anxiety during relaxation exercises.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment, 12-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment, 12-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 Consumption and Drug Use at 1-month
Change from Baseline Alcohol Consumption and Drug Use at 12-months
Change from Baseline Alcohol Consumption and Drug Use at 3-months
+5 moreSecondary study objectives
Anxiety
Change from Baseline Alcohol Purchase Task responses at 1-month
Change from Baseline Alcohol Purchase Task responses at 12-months
+13 moreAwards & 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: Relaxation Training (RT) + Substance Free Activity Session (SFAS)Experimental Treatment2 Interventions
Participants will complete a relaxation training session that will include a clinician leading them through a diaphragmatic breathing exercise, a progressive muscle relaxation protocol, and then a brief breath-counting (mindfulness) exercise. A week later, the participant will receive the SFAS, a 50-minute counseling session designed to increase the salience of the individual's goals, to highlight the connection between their current patterns of behavior (including drinking and substance-free activities) and the attainment of these goals, and to increase future orientation and engagement in enjoyable and goal-directed activities that are inconsistent with substance use (even if the participant has no desire to change their use).
Group II: Brief Alcohol Intervention (BAI) + Substance Free Activity Session (SFAS)Experimental Treatment2 Interventions
Participants first receive a 50-minute standard brief motivational intervention designed to reduce alcohol use. A week later, they will receive the Substance-free activity session (SFAS), a 50-minute counseling session designed to increase the salience of the individual's goals, to highlight the connection between their current patterns of behavior (including drinking and substance-free activities) and the attainment of these goals, and to increase future orientation and engagement in enjoyable and goal-directed activities that are inconsistent with substance use (even if the participant has no desire to change their use).
Group III: Education ControlActive Control1 Intervention
This minimal contact control condition will include a brief (2-3 minute) discussion where the research assistant (RA) who completed the assessment session will describe the educational handout. This condition is meant to approximate a public health-level approach to providing referral information and some of the content included in the BAI+SFAS condition but without any of the personalized information or motivational interviewing. Participants will receive information on risks associated with alcohol/drug misuse, strategies for reducing alcohol problems, managing stress, and goal-setting. The handout will also include links to hotlines, websites, and apps related to these domains. This condition will not include booster contact
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Relaxation Training (RT)
2009
N/A
~90
Find a Location
Who is running the clinical trial?
University of MemphisLead Sponsor
71 Previous Clinical Trials
11,406 Total Patients Enrolled
2 Trials studying Alcoholism
506 Patients Enrolled for Alcoholism
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 29 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Brief Alcohol Intervention (BAI) + Substance Free Activity Session (SFAS)
- Group 2: Education Control
- Group 3: Relaxation Training (RT) + Substance Free Activity Session (SFAS)
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.
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