Guanfacine to Improve Substance Use Outcomes in Women

Yale University74 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Substance Use Disorders

Interventions

GuanfacineDRUG

Guanfacine 3mg/day Versus Placebo

Behavioral CounselingOTHER

placebo

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Yale Stress Center: Yale University

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Change in Drug Use With Substance Use Calendar

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.

Time frame: 10 weeks

Change in Abstinence Days

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.

Time frame: 10 weeks

Secondary Outcomes

Change in Average Drug Craving

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.

Time frame: 10 weeks

Number of Participants With Treatment Emergent Adverse Event

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.

Time frame: 10 weeks

Data from ClinicalTrials.gov

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