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Abstinence from Alcohol for Alcoholism (SPAR Trial)

N/A
Recruiting
Led By Martin H Plawecki, MD, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to understand/complete questionnaires and procedures in English
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

SPAR Trial Summary

This trial will study how men and women respond to abstinence from alcohol, and whether this information can be used to improve intervention and prevention strategies.

Who is the study for?
This trial is for moderate social drinkers with a BMI between 18.5 and 32 kg/m2 who can understand English. It's not for those with certain mental disorders, history of severe head injury, suicidal tendencies, pregnant or breastfeeding women, people on medications like antidepressants that could affect the study, or anyone court-ordered to abstain from alcohol.Check my eligibility
What is being tested?
The study examines how men and women respond differently to not drinking alcohol compared to their usual consumption. The goal is to see if this information can help tailor better prevention and intervention strategies for alcoholism.See study design
What are the potential side effects?
Since the interventions involve abstinence from alcohol or continuing usual drinking habits rather than medication, typical drug side effects are not expected. However, participants may experience withdrawal symptoms or psychological effects due to changes in their drinking patterns.

SPAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can understand and fill out questionnaires in English.

SPAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response to abstinence as a predictor of alcohol risk in women and men.
Sex differences in the effect of abstinence on alcohol self-administration.
Sex differences in the effect of abstinence on sensitivity of the P3 response to alcohol.
+2 more

SPAR Trial Design

3Treatment groups
Experimental Treatment
Group I: Free access alcohol self-administrationExperimental Treatment2 Interventions
During the 2.5-hour free-access self-administration sessions, the participant may choose to complete a task for an alcohol or water reward. Interventions include Abstinence from Alcohol and Usual Drinking
Group II: Clamped alcohol exposureExperimental Treatment2 Interventions
A battery of behavioral tasks will be administered to participants before, and at the beginning and end of a 3 hour clamped exposure to alcohol (fixed at 80 mg/dL). EEG will be recorded throughout to assess event related potentials associated with task performance. Interventions include Abstinence from Alcohol and Usual Drinking.
Group III: 2 year followupExperimental Treatment2 Interventions
Participants from both Arm 1 and Arm 2 will be surveyed every 2 months for alcohol consumption for 2 years following the Experimental phase. Interventions include Abstinence from Alcohol and Usual Drinking.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
977 Previous Clinical Trials
983,153 Total Patients Enrolled
9 Trials studying Alcoholism
1,326 Patients Enrolled for Alcoholism
Martin H Plawecki, MD, PhDPrincipal InvestigatorPsychiatry, Indiana University School of Medicine
2 Previous Clinical Trials
228 Total Patients Enrolled
2 Trials studying Alcoholism
228 Patients Enrolled for Alcoholism
Melissa A Cyders, PhDPrincipal InvestigatorPsychology, Indiana University-Purdue University at Indianapolis
1 Previous Clinical Trials
216 Total Patients Enrolled
1 Trials studying Alcoholism
216 Patients Enrolled for Alcoholism

Media Library

Abstinence from alcohol Clinical Trial Eligibility Overview. Trial Name: NCT03827460 — N/A
Alcoholism Research Study Groups: Free access alcohol self-administration, Clamped alcohol exposure, 2 year followup
Alcoholism Clinical Trial 2023: Abstinence from alcohol Highlights & Side Effects. Trial Name: NCT03827460 — N/A
Abstinence from alcohol 2023 Treatment Timeline for Medical Study. Trial Name: NCT03827460 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria for enrollment in this experiment?

"This clinical trial seeks 160 subjects, aged 21 to 35 years old, with alcohol use disorder. Additionally, participants must meet the criteria of a moderate social drinker and have a BMI between 18.5 - 32 kg/m2."

Answered by AI

Is enrollment for this research project still ongoing?

"According to the information housed on clinicaltrials.gov, recruitment is still underway for this medical trial which was initially posted in April of 2019 and updated as recently as July 21st 2022."

Answered by AI

How many individuals have volunteered for this research project?

"Correct. According to the information available on clinicaltrials.gov, this experiment is actively recruiting participants after being posted in April 10th 2019 and updated most recently on July 21st 2022. A total of 160 individuals are needed for enrollment at a single site."

Answered by AI

Are minors within the age range of this research trial?

"The study is searching for volunteers between the ages of 21 and 35 to participate."

Answered by AI
~0 spots leftby Mar 2024