Guanfacine to Improve Substance Use Outcomes in Women

NCT03980184 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 20000231001R01DA047094-01A1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  10 weeks

Secondary Outcomes (2)

• Change in Average Drug Craving

  10 weeks

• Number of Participants With Treatment Emergent Adverse Event

  10 weeks

Other Outcomes (3)

• Change in Stress Scores

  10 weeks

• Change in Anxiety Levels

  10 weeks

• Change in Depression Levels

  10 weeks

Study Arms (2)

Study Medication

EXPERIMENTAL

guanfacine 3mg/day (GUA)

Drug: Guanfacine; Other: Behavioral Counseling

placebo

PLACEBO COMPARATOR

placebo (PBO)

Drug: Guanfacine; Other: Behavioral Counseling

Interventions

Guanfacine DRUG

Guanfacine 3mg/day Versus Placebo

Also known as: Tenex,

Study Medication; placebo

Behavioral Counseling OTHER

placebo

Also known as: Manualized Drug Counseling

Study Medication; placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: treatment seeking women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Yale Stress Center: Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Guanfacine; Behavior Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Small sample sizes, sample being limited to men were limitations. Caveats include small sample size limited examining treatment effects for specific drug use. Also, medication compliance moderated guanfacine effects on primary and secondary outcomes.

Results Point of Contact

• Title: Rajita Sinha, PhD, Study PI
• Organization: Yale University

rajita.sinha@yale.edu

203-737-5805

Study Officials

• Rajita Sinha, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry,

Model Details: randomized double blind, placebo controlled

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: June 10, 2019
• Study Start: November 1, 2019
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: March 20, 2024
• Results First Posted: January 8, 2024

Record last verified: 2024-03

Locations

US (1)