Substance Use Disorders Clinical Trial
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).
Verified date | March 2024 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | November 30, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The Yale Stress Center: Yale University | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Stress Scores | Repeated assessment of 14-item Perceived Stress Scale (score range: 0-53, higher scores are worse) assessed weekly. Scores are the average change between week 10 and week 1. | 10 weeks | |
Other | Change in Anxiety Levels | Repeated assessment of 14-item Hamilton Anxiety Scale (score range: 0-56, higher score is worse outcome) assessed weekly over 10 weeks. Scores are the average change between week 10 and week 1. | 10 weeks | |
Other | Change in Depression Levels | Repeated assessment of 17-item Hamilton Depression Scale (score range: 0-53, higher score is worse outcome) assessed weekly over 10 weeks. Scores are the average change between week 10 and week 1. | 10 weeks | |
Primary | 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 | |
Primary | 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 | Change in Average Drug Craving | Sum of average drug craving measured using Craving Questionnaires for cocaine, opiates, alcohol, nicotine and cannabis.The possible range for the average craving measure is 0 - 100. A higher score on the measure = greater avg drug craving. | 10 weeks | |
Secondary | Number of Participants With Treatment Emergent Adverse Event | The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial. Data presented here is the number of participants that had any adverse events while on study. | 10 weeks |
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