Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
100

Summary

Conditions
Substance Use Disorders
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: randomized double blindMasking: Double (Participant, Care Provider)Masking Description: double blindPrimary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 70 years
Gender
Only males

Description

This study proposes to extend previous Phase I experimental work to address the following specific aims: (1) assess GUA's target engagement of drug craving and cognitive flexibility in a laboratory challenge session and in a 10-week outpatient clinical study, (2) demonstrate target validation by sho...

This study proposes to extend previous Phase I experimental work to address the following specific aims: (1) assess GUA's target engagement of drug craving and cognitive flexibility in a laboratory challenge session and in a 10-week outpatient clinical study, (2) demonstrate target validation by showing that reduced drug craving and improved cognitive flexibility will predict lower drug use outcomes during the 10-week clinical trial in SUD women, and finally, (3) evaluate data replication and scalability of GUA target effects across two clinical sites (Yale and SUNY-Stony Brook).

Tracking Information

NCT #
NCT03980184
Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Rajita Sinha, PhD Yale University