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Behavioral Intervention

Combination Therapy for Alcohol Consumption and Problem Drinking (FIRST Trial)

N/A
Waitlist Available
Led By David Fiellin, MD
Research Sponsored by Yale University
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 month
Awards & highlights

FIRST Trial Summary

This trial will test whether giving rewards for staying sober can help HIV-positive patients with alcohol problems.

Eligible Conditions
  • Problem Drinking

FIRST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Self-reported Abstinence From Alcohol
Secondary outcome measures
Change in Biological Markers as Measured by the VACS Index
Proportion of Participants of Participants With Phosphatidylethanol (PeTH) Documented Abstinence by the Alcohol Biomarker, Phosphatidylethanol (PEth)
Other outcome measures
Depressive Symptoms Via PHQ-9
Liver Fibrosis Based on Fibrosis-4 (FIB-4) Score
Recent Receipt of a Psychoactive Medication That May Interact With Alcohol
+3 more

FIRST Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Contingency Management plus Stepped Care (Step 2)Experimental Treatment3 Interventions
Step 1: Contingency management; Step 2: Addiction physician management and motivational enhancement therapy Consistent with tenets of stepped care designs we provide a priori intervals and criteria (drinking targets) that dictate increasing the intensity of treatment (stepping up) based on research and standards in the field. All CM plus stepped care subjects will undergo PEth testing at 3 months to determine the efficacy of Step 1. Patients with a PEth > 8 ng/ml will continue on to Step 2.
Group II: Treatment As Usual (TAU)Active Control1 Intervention
We have elected to compare the CM plus stepped care condition to TAU to test its efficacy against a "real world" control and because CM plus stepped care is a comprehensive stand alone intervention that would substitute for TAU. While annual AUDIT-C screening is mandatory at the 7 sites, providing interventions for patients with unhealthy alcohol use is a matter of physician judgment and individual clinical practice with wide practice variation. HIV clinicians will not receive knowledge of the results of follow-up research assessments. We will conduct a Treatment Services Review at each follow-up to assess for receipt of addiction treatment services received since the last assessment and assess for contamination.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Addiction Physician Management
2018
N/A
~120
Contingency Management Counseling
2018
N/A
~120
Motivational Enhancement Therapy
2018
Completed Phase 2
~5050

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
808 Previous Clinical Trials
1,158,006 Total Patients Enrolled
5 Trials studying Problem Drinking
2,049 Patients Enrolled for Problem Drinking
Yale UniversityLead Sponsor
1,862 Previous Clinical Trials
2,742,448 Total Patients Enrolled
2 Trials studying Problem Drinking
157 Patients Enrolled for Problem Drinking
VA Connecticut Healthcare SystemFED
81 Previous Clinical Trials
6,545 Total Patients Enrolled

Media Library

Contingency Management Counseling (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03089320 — N/A
Problem Drinking Research Study Groups: Treatment As Usual (TAU), Contingency Management plus Stepped Care (Step 2)
Problem Drinking Clinical Trial 2023: Contingency Management Counseling Highlights & Side Effects. Trial Name: NCT03089320 — N/A
Contingency Management Counseling (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03089320 — N/A
Problem Drinking Patient Testimony for trial: Trial Name: NCT03089320 — N/A

Frequently Asked Questions

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

Is this trial actively seeking participants right now?

"Unfortunately, this medical study is not currently recruiting any participants. It was initially published on May 1st 2018 and has been edited as recently as October 10th 2022. However, there are 245 other clinical trials actively seeking patient participation."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
What site did they apply to?
Louisiana Health Sciences Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

It the first trial I’ve seen that addresses two of my conditions (HIV+ and alcohol use) jointly.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Louisiana Health Sciences Center: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Financial Incentives, Randomization With Stepped Treatment Trial
2018. "Financial Incentives, Randomization With Stepped Treatment Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03089320.
~17 spots leftby May 2025
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