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Alpha-2A Adrenergic Receptor Agonist

Guanfacine for Substance Use Disorder

Phase 2
Waitlist Available
Led By Rajita Sinha, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

This trial will test if guanfacine can help reduce drug craving and improve cognitive flexibility in women with substance use disorder in an outpatient setting.

Eligible Conditions
  • Substance Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Abstinence Days
Change in Drug Use With Substance Use Calendar
Secondary outcome measures
Change in Average Drug Craving
Number of Participants With Treatment Emergent Adverse Event
Other outcome measures
Change in Anxiety Levels
Change in Depression Levels
Change in Stress Scores

Side effects data

From 2011 Phase 4 trial • 212 Patients • NCT00429273
36%
Decreased Appetite
34%
Insomnia
33%
Headache
26%
Irritability
23%
Abdominal Pain
23%
Sedation
23%
Lethargy
21%
Somnolence
17%
Fatigue
14%
Abdominal Pain Upper
11%
Affect Lability
10%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Guan-Guan+Placebo
Group 2: Placebo-Placebo+DMPH
Group 3: Guan-Guan+DMPH

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Study MedicationExperimental Treatment2 Interventions
guanfacine 3mg/day (GUA)
Group II: placeboPlacebo Group2 Interventions
placebo (PBO)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guanfacine
FDA approved

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,519 Total Patients Enrolled
Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,736,454 Total Patients Enrolled
Rajita Sinha, PhDPrincipal InvestigatorYale University
13 Previous Clinical Trials
2,025 Total Patients Enrolled

Media Library

Substance Use Disorder Clinical Trial 2023: Guanfacine Highlights & Side Effects. Trial Name: NCT03980184 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Guanfacine been given a green light by the FDA?

"While there is some clinical evidence of the safety profile for Guanfacine, efficacy has yet to be proven. As such, our team at Power assigned it a score of 2 on the risk scale from 1-3."

Answered by AI

Does this research program accept elderly participants?

"This trial has outlined that applicants between 18 and 70 years of age are eligible to participate. There is a total of 77 trials for minors, while those above the retirement threshold have access to 260 different studies."

Answered by AI

Has there been any prior research concerning the effects of Guanfacine?

"Currently, there are 9 trials exploring the effects of guanfacine with 2 in Phase 3. The overwhelming majority of these studies have been set up at locations across Palo Alto, California. In total, 80 clinical sites now offer this medication for study and research purposes."

Answered by AI

Can you elucidate the primary conditions which can be alleviated by taking Guanfacine?

"Guanfacine is frequently dispensed to alleviate migraine symptoms. Other conditions that can be treated with guanfacine include attention deficit hyperactivity disorder (ADHD), hypertensive disease, and prevention of migraines."

Answered by AI

Is enrollment for this research still open?

"Verified. According to the information found on clinicaltrials.gov, this medical trial is in search of participants and was first made available for recruitment on November 1st 2019. Recent updates were applied on July 22nd 2022 and it aims to enrol 14 patients from a single site."

Answered by AI

How many participants are actively involved in this investigation?

"Affirmative. Clinicaltrials.gov shows that this clinical study, which first went live on the 1st of November 2019, is now actively recruiting participants. A total of 14 people needs to be sourced from a single medical centre for the trial to move forward."

Answered by AI

What criteria must be met in order for a person to qualify for this medical experiment?

"This medical trial requires 14 individuals, ranging in age from 18 to 70 years old who have a drug addiction. Patients must additionally fulfil the following requirements: 100 treatment-seeking females, informed verbal and written consent indicating they meet DSM-V criteria for concurrent Substance Use Disorders (SUDs) with either primary cocaine or opioid use disorder plus co-occurring cannabis, alcohol or nicotine abuse; BMI between 18 and 35."

Answered by AI

Is this medical experiment the inaugural effort of its kind?

"Presently, there are 9 ongoing studies on guanfacine that span multiple cities and countries. Shire initially sponsored a trial of 20 participants in 2018 which has since been concluded. Since then, 52 experiments have successfully finished."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Guanfacine to Improve Substance Use Outcomes in Women
RAJITA SINHA 2019. "Guanfacine to Improve Substance Use Outcomes in Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03980184.
~14 spots leftby Apr 2025
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