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Phase II

Guanfacine to Improve Substance Use Outcomes in Women

  • Study HIC#:2000025416
  • Last Updated:07/15/2021

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).

  • Age18 years - 55 years
  • GenderFemale only
  • Start Date09/17/2019
  • End Date06/30/2021

Trial Purpose and Description

The current study will test GUA (3 mg/day) vs Placebo (PBO) in a 10-week clinical trial across 2 sites in a total of 100 SUD women.

All participants will be titrated to steady-state medication levels over 2 weeks followed by a 7-week treatment period using a standard cognitive behavioral relapse prevention with medication management and contingency management (CM) for treatment attendance. A 5-day taper will be implemented in week 10. All participants will also take part in two laboratory challenge test sessions: one at pre-treatment (pre-tx) and one during week 9 of treatment, to assess provoked drug craving and cognitive flexibility under stress, drug cue and neutral cue conditions in a randomized and counterbalanced order.

Eligibility Criteria

Inclusion Criteria:

  • 100 treatment seeking women
  • Ages 18-55 years
  • Body mass index (BMI) of 18-35
  • Meet current DSM-V criteria for co-occurring SUDs, with primary DSM-V cocaine 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, alcohol, nicotine or cannabis
  • Meet criteria for physiological dependence on alcohol requiring medical detoxification
  • Current use of opiates
  • Regular use of anticonvulsants, sedatives/hypnotics, prescription analgesics, other anti-hypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, naltrexone, disulfiram, and any other psychoactive medications with the exception of individuals stabilized on Selective Serotonin Reuptake Inhibitors (SSRI)
  • 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
  • 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.

Principal Investigator

Sub-Investigators

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