Guanfacine to Improve Substance Use Outcomes in Women

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Guanfacine

Criteria

Inclusion Criteria:

• 100 treatment seeking women

• Ages 18-70 years

• Body mass index (BMI) of 18-35

• Meet current DSM-V criteria for co-occurring SUDs, with primary DSM-V cocaine or primary DSM-V opioid use disorder AND co-occurring cannabis or alcohol or nicotine use disorders;

• Positive drug urine toxicology screens for primary addictive disorder during a 2-week intake assessment period

• Good health as verified by screening examination

• Able to read English and complete study evaluations

• Able to provide informed written and verbal consent

Exclusion Criteria:

• Meet criteria for current SUD on other psychoactive substance, excluding cocaine, opioid, alcohol, nicotine or cannabis

• Meet criteria for physiological dependence on alcohol requiring medical detoxification

• Regular use of anti-hypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants;

• Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania)

• Significant underlying medical conditions which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study; Specifically hepatic and renal impairment as per liver enzymes at 3X the normal limit, or BUN>50mg or BUN:Cr > 10:1.

• Hypotensive women with sitting blood pressure below 100/50 mmHG

• Women who are pregnant, nursing or refuse to use a reliable form of birth control

• EKG evidence at baseline screening of any clinically significant conduction abnormalities, including a Bazlett's QT c>470 msec for women.