Clinical trial NCT03980184: Guanfacine to Improve Substance Use Outcomes in Women
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance Use Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-06-10
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double blind, placebo controlled
Primary purpose: PREVENTION

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).

Eligibility 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 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.

Primary outcomes:
measure: Change in Drug Use With Substance Use Calendar
timeFrame: 10 weeks
measure: Change in Abstinence Days
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in Average Drug Craving
timeFrame: 10 weeks
measure: Number of Participants With Treatment Emergent Adverse Event
timeFrame: 10 weeks
Other outcomes:
measure: Change in Stress Scores
timeFrame: 10 weeks
measure: Change in Anxiety Levels
timeFrame: 10 weeks
measure: Change in Depression Levels
timeFrame: 10 weeks
Locations:
city: New Haven
country: United States
facility: The Yale Stress Center: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Rajita Sinha, PhD
role: PRINCIPAL_INVESTIGATOR
References: