NCT03980184

Guanfacine to Improve Substance Use Outcomes in Women

The Use of Guanfacine (GUA) (3mg/Day) to Reduce Drug Craving, Improve Cognitive Flexibility and Result in Associated Lower Drug Use in Women With Substance Use Disorder (SUD).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Hypothesis: Guanfacine (GUA) (3mg/day) will reduce drug craving, improve cognitive flexibility and result in associated lower drug use in women with substance use disorder (SUD) in an outpatient clinical setting.

Detailed 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 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).

Conditions

• Substance Use Disorders

Interventions

Type	Name	Description
DRUG	Guanfacine	Guanfacine 3mg/day Versus Placebo
OTHER	Behavioral Counseling	placebo

Timeline

• Start date: 2019-11-01
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2019-06-10
• Last updated: 2024-03-20
• Results posted: 2024-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study