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Abstinence from Alcohol for Alcoholism (SPAR Trial)

Phase 1

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

Must not have

Medications (past 30 days) that could influence data or participant safety (e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by investigators

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and fill out questionnaires in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any medications in the last 30 days that could affect my safety or the study results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & 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: Free access alcohol self-administrationExperimental Treatment3 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 Treatment3 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 followupActive Control2 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.

0 / 2Eligibility criteria met