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Guanfacine to Improve Substance Use Outcomes in Women

Primary Purpose

Substance Use Disorders

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Guanfacine

Behavioral Counseling

About this trial

This is an interventional prevention trial for Substance Use Disorders

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 current SUD on other psychoactive substance, excluding cocaine, opioid, alcohol, nicotine or cannabis
Meet criteria for physiological dependence on alcohol requiring medical detoxification
Regular use of anti-hypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants;
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.

Sites / Locations

The Yale Stress Center: Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Medication

placebo

Arm Description

guanfacine 3mg/day (GUA)

placebo (PBO)

Outcomes

Primary Outcome Measures

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)

Change in abstinence days

Substance use calendar self report of daily drug use during 10 week treatment periods

Secondary Outcome Measures

Change in average drug craving

Sum of average drug craving measured using Craving Questionnaires for cocaine, opiates, alcohol, nicotine and cannabis.

Adverse events

Baseline and weekly assessment of SAFTEE questionnaire

Full Information

NCT ID

NCT03980184

First Posted

March 29, 2019

Last Updated

July 5, 2023

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT03980184

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

November 30, 2022 (Actual)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Use Disorders

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

randomized double blind, placebo controlled

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

double blind

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Medication

Arm Type

Experimental

Arm Description

guanfacine 3mg/day (GUA)

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo (PBO)

Intervention Type

Drug

Intervention Name(s)

Guanfacine

Other Intervention Name(s)

Tenex,

Intervention Description

Guanfacine 3mg/day Versus Placebo

Intervention Type

Other

Intervention Name(s)

Behavioral Counseling

Other Intervention Name(s)

Manualized Drug Counseling

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Change in drug use with Substance Use Calendar

Description

Days of any drug use during the 10 week period (assessed daily and weekly via self report)

Time Frame

10 weeks

Title

Change in abstinence days

Description

Substance use calendar self report of daily drug use during 10 week treatment periods

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

Change in average drug craving

Description

Sum of average drug craving measured using Craving Questionnaires for cocaine, opiates, alcohol, nicotine and cannabis.

Time Frame

10 weeks

Title

Adverse events

Description

Baseline and weekly assessment of SAFTEE questionnaire

Time Frame

10 weeks

Other Pre-specified Outcome Measures:

Title

Change in Stress scores

Description

Repeated assessment of 14-item Perceived Stress Scale (score range: 0-53, higher scores are worse) assessed weekly

Time Frame

10 weeks

Title

Change in anxiety levels

Description

Repeated assessment of 14-item Hamilton Anxiety Scale (score range: 0-56, higher score is worse outcome) assessed weekly over 10 weeks

Time Frame

10 weeks

Title

Change in depression levels

Description

Repeated assessment of 17-item Hamilton Depression Scale (score range: 0-53, higher score is worse outcome) assessed weekly over 10 weeks

Time Frame

10 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

treatment seeking women

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rajita Sinha, PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Yale Stress Center: Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

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Guanfacine to Improve Substance Use Outcomes in Women

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