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New treatment option for Alcohol Use
Official title Mechanistic Evaluation of Guanfacine on Drinking Behavior in Women and Men With Alcohol Use Disorders
ClinicalTrials.gov ID: NCT03764098
What this study is testing
What is Guanfacine ER?
Guanfacine ER is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for alcohol use.
Also referred to as Intuniv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- For this protocol, the investigators plan to collect pilot data to examine sex differences in guanfacine's effect on 1) counteracting stress and stimulation based drinking behavior in the laboratory and 2) improving clinical outcomes during a subsequent treatment phase.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Age 21 70;
- Able to read and write English;
- Meets DSM V criteria for current (past 6 months) alcohol use disorder or Drinking criteria: Males Drinks more than 14 drinks per week and exceeds 4...
- Laboratory sessions will be scheduled such that people will not have major responsibilities on the following day which might limit drinking during...
- Able to take oral medications and willing to adhere to medication regimen;
You likely can't join if
- people with any significant current medical conditions (neurological, cardiovascular [including hypertension or hypotension: sitting BP more than...
- Current DSM V substance use disorder, other than alcohol abuse disorder or nicotine dependence;
- A positive test result at intake appointment on urine drug screens conducted for illicit drugs;
- Past 30 day use of psychoactive drugs including anxiolytics and antidepressants;
- Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is...
- Suicidal, homicidal or evidence of current (past 6 month) mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety...
See the full eligibility criteria
- Age 21 70;
- Able to read and write English;
- Meets DSM V criteria for current (past 6 months) alcohol use disorder or Drinking criteria: Males Drinks more than 14 drinks per week and exceeds 4 drinks per day at least twice per week; Females Drinks \> more than 7...
- Laboratory sessions will be scheduled such that people will not have major responsibilities on the following day which might limit drinking during the self administration session (e.g., job interview, exam);
- Able to take oral medications and willing to adhere to medication regimen;
- indicate willingness to cut down on drinking during the treatment period.
- people with any significant current medical conditions (neurological, cardiovascular [including hypertension or hypotension: sitting BP more than 160/100 or less than 90/60mmHg at baseline screening], endocrine...
- Current DSM V substance use disorder, other than alcohol abuse disorder or nicotine dependence;
- A positive test result at intake appointment on urine drug screens conducted for illicit drugs;
- Past 30 day use of psychoactive drugs including anxiolytics and antidepressants;
- Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection...
- Suicidal, homicidal or evidence of current (past 6 month) mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders;
- Meet DSM V criteria for current (past 6 month) ADHD;
- Only one member per household can participate in the study
- Specific exclusions for administration of guanfacine not already specified include: EKG evidence at baseline screening of any clinically significant conduction abnormalities or arrhythmias; known intolerance for...
- people likely to exhibit clinically significant alcohol withdrawal during the study. Specifically, we will exclude people who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon...
- people who have taken any investigational drug within 4 weeks immediately preceding admission to the treatment period;
- Participation within the past 8 weeks in other studies that involve additive blood sampling and/or treatment measures that would be considered excessive in combination with the current application;
- at intake express desire to completely abstain from alcohol;
- currently in treatment for alcohol use
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.