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).
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Change in Drug Use With Substance Use Calendar
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
double blind
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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:
- •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.
Arms & Interventions
placebo
placebo (PBO)
Intervention: Behavioral Counseling (Other)
Study Medication
guanfacine 3mg/day (GUA)
Intervention: Guanfacine (Drug)
Study Medication
guanfacine 3mg/day (GUA)
Intervention: Behavioral Counseling (Other)
placebo
placebo (PBO)
Intervention: Guanfacine (Drug)
Outcomes
Primary Outcomes
Change in Drug Use With Substance Use Calendar
Time Frame: 10 weeks
Days of any drug use during the 10 week period (assessed daily and weekly via self report). Data presented here is the average between week 10 and week 1.
Change in Abstinence Days
Time Frame: 10 weeks
Substance use calendar self report of daily drug use during 10 week treatment periods. Data presented here is the average between week 10 and week 1.
Secondary Outcomes
- Change in Average Drug Craving(10 weeks)
- Number of Participants With Treatment Emergent Adverse Event(10 weeks)
Investigators
RAJITA SINHA
Professor, Department of Psychiatry,
Yale University