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Nicotinic Acetylcholine Receptor Partial Agonist
Varenicline for Cannabis Use Disorder
Phase 2
Waitlist Available
Led By Aimee McRae-Clark, PharmD
Research Sponsored by Medical University of South Carolina
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 treatment phase weeks 6-12
Awards & highlights
Study Summary
This trial will test if varenicline, a drug typically used to quit smoking, can help people reduce their marijuana use.
Eligible Conditions
- Cannabis Use Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment phase weeks 6-12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment phase weeks 6-12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions
Secondary outcome measures
Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder
Side effects data
From 2022 Phase 4 trial • 39 Patients • NCT0401128050%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Depression
21%
Agitation
21%
Headache
14%
Allergies
14%
Heartburn
14%
Cold
14%
Back Pain
7%
Cellulitis
7%
Sinusitis
7%
Stomach Pain
7%
Panic
7%
Angina
7%
Aggression
7%
Palpitations
7%
Rash
7%
Confusion
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Increased Blood Pressure
7%
Malaise
7%
Weight Gain
7%
Gum Disease
7%
Pharyngitis
7%
Leg Cramps
7%
Muscle Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose Varenicline
Standard Dose Varenicline
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VareniclineExperimental Treatment1 Intervention
2 mg daily
Group II: PlaceboPlacebo Group1 Intervention
2 mg daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
FDA approved
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,441 Total Patients Enrolled
Aimee McRae-Clark, PharmDPrincipal InvestigatorMedical University of South Carolina
2 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have shown suicidal behavior in the past 10 years or have a history of serious or repeated suicidal behavior.You want to receive treatment to reduce your cannabis use.You have a diagnosed condition called cannabis use disorder and you have been using cannabis at least three days a week for the past month.You are currently taking medications for conditions like extreme mood swings or hallucinations.You are currently taking bupropion or nortriptyline.You have been using drugs other than tobacco heavily in the past 60 days.You have had a problem with drinking too much alcohol in the past year or currently.You are allergic to varenicline.You are not planning to start or change how often you attend self-help meetings like Alcoholics Anonymous or Narcotics Anonymous.You are interested in getting help for your problem with using cannabis and want to reduce your usage.You have experienced severe stress or trauma in the past year or are currently diagnosed with post-traumatic stress disorder (PTSD).You have had a stroke or other serious brain-related condition in the past 6 months.You currently have thoughts of hurting yourself or have had a plan to do so in the past year.You have a total score of 8 or higher on a questionnaire about suicidal thoughts, or the researcher believes you need a risk assessment by a qualified medical professional. If you answer 'yes' to questions 4 or 5 about suicidal thoughts, you will be referred to a mental health professional for assessment.
Research Study Groups:
This trial has the following groups:- Group 1: Varenicline
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cannabis Use Disorder Patient Testimony for trial: Trial Name: NCT03980561 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have there been any other investigations into the efficacy of Varenicline?
"Presently, 26 separate clinical trials are being run to evaluate the efficacy of Varenicline. 4 of those experiments are in their third phase. Despite most studies for this drug centering around Charleston, South carolina, there is a total of 69 sites running research into its potential applications."
Answered by AI
What safety measures have been implemented for Varenicline use?
"There is existing evidence of the safety profile of Varenicline, so we assigned it a rating of 2. Nevertheless, there are no clinical data available to attest to its efficacy in this Phase 2 trial."
Answered by AI
What is the size of the participant pool for this research experiment?
"The current recruitment window has closed for this particular trial, which was initially listed on January 31st 2020 and the most recent update being posted November 3rd 2022. However, there are currently 117 studies looking to recruit individuals with a history of cannabis abuse as well as 26 trials recruiting volunteers taking Varenicline."
Answered by AI
Is the enrollment period for this trial still ongoing?
"At present, this clinical trial is in a dormant phase; having been first posted on January 31st 2020 and last updated November 3rd 2022. However, for those seeking other trials there are 117 available involving hashish abuse and 26 pertaining to Varenicline."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
Behavioral Health Services of Pickens County
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have been experiencing CHS for some years now, and looking forward to finally finding out more information about the condition and to prevent future THC consumption knowing the harmful side effects.
PatientReceived no prior treatments
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