Guanfacine to Improve Substance Use Outcomes in Women

Yale University

Status and phase: Completed; Phase 2

Conditions: Substance Use Disorders

Treatments: Other: Behavioral Counseling; Drug: Guanfacine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03980184

2000023100

1R01DA047094-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 74 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 physiological dependence on alcohol requiring medical detoxification
• Regular use of anti-hypertensives, anti-arrythmics, antiretroviral medications, and medications that would interact with Guanfacine and be contraindicated as per study physician;
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

74 participants in 2 patient groups, including a placebo group

Study Medication

Experimental group

Description:

guanfacine 3mg/day (GUA)

Treatment:

Drug: Guanfacine

Other: Behavioral Counseling

placebo

Placebo Comparator group

Description:

placebo (PBO)

Treatment:

Drug: Guanfacine

Other: Behavioral Counseling