Guanfacine to Improve Substance Use Outcomes in Women

NCT ID: NCT03980184

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2022-11-30

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).

Conditions

Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Study Medication

guanfacine 3mg/day (GUA)

Group Type: EXPERIMENTAL

Guanfacine

Intervention Type: DRUG

Guanfacine 3mg/day Versus Placebo

Behavioral Counseling

Intervention Type: OTHER

placebo

placebo

placebo (PBO)

Group Type: PLACEBO_COMPARATOR

Guanfacine

Intervention Type: DRUG

Guanfacine 3mg/day Versus Placebo

Behavioral Counseling

Intervention Type: OTHER

placebo

Interventions

Guanfacine

Guanfacine 3mg/day Versus Placebo

Intervention Type: DRUG

Behavioral Counseling

placebo

Intervention Type: OTHER

Other Intervention Names

Tenex,; Manualized Drug Counseling

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Responsible Party

RAJITA SINHA

Professor, Department of Psychiatry,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajita Sinha, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

The Yale Stress Center: Yale University

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DA047094-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000023100

Identifier Type: -

Identifier Source: org_study_id