Guanfacine to Improve Substance Use Outcomes in Women
- Study HIC#:2000025416
- Last Updated:07/15/2021
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.
- 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
- 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.