Guanfacine to Improve Substance Use Outcomes in Women

Phase 2

Completed

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).

Recruitment & Eligibility

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.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Change in Drug Use With Substance Use Calendar	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	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 Outcome Measures

Name	Time	Method
Change in Average Drug Craving	10 weeks	Sum of average drug craving measured using Craving Questionnaires for cocaine, opiates, alcohol, nicotine and cannabis.The possible range for the average craving measure is 0 - 100. A higher score on the measure = greater avg drug craving.
Number of Participants With Treatment Emergent Adverse Event	10 weeks	The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial. Data presented here is the number of participants that had any adverse events while on study.