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Nicotinic Acetylcholine Receptor Partial Agonist
Varenicline for Methamphetamine Abuse
Phase 1
Waitlist Available
Led By Edythe D London, Ph.D.
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights
Summary
This trial is testing varenicline, a medication usually used to help people quit smoking, on methamphetamine users. The goal is to see if it can improve brain function and connectivity. Researchers hope this will also enhance cognitive abilities in these patients.
Eligible Conditions
- Dopamine Receptor Availability
- Cognitive Functioning
- Methamphetamine Abuse
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dopamine D2-type receptor availability
Secondary study objectives
Decision making under risk and ambiguity
Declarative memory
Inhibitory control - reversal learning
+8 moreOther study objectives
Personality - impulsivity
Personality - novelty seeking
Personality - reward dependence
Side effects data
From 2022 Phase 4 trial • 39 Patients • NCT0401128050%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Agitation
21%
Depression
21%
Headache
14%
Heartburn
14%
Allergies
14%
Cold
14%
Back Pain
7%
Confusion
7%
Aggression
7%
Panic
7%
Stomach Pain
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Sinusitis
7%
Angina
7%
Increased Blood Pressure
7%
Palpitations
7%
Cellulitis
7%
Rash
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
A standard dose titration regimen that is used for smoking-cessation will be followed. The pharmacist will prepare capsules of varenicline for each week of study participation. Under observation by a study clinician, participants will receive one capsule containing 0.5 mg VAR each day (0900 h) for 3 days, then one capsule containing 0.5 mg VAR twice daily (0900 h, 2100 h) for 4 days, and finally a capsule containing 1 mg VAR twice daily (0900 h, 2100 h) for the next 2 weeks.
Group II: PlaceboPlacebo Group1 Intervention
The same procedure used for varenicline treatment will be followed. The pharmacist will prepare capsules of placebo for each week of study participation. Under observation by a study clinician, participants will receive one capsule containing placebo each day (0900 h) for 3 days, then one capsule containing placebo twice daily (0900 h, 2100 h) for 4 days, and finally a capsule containing placebo twice daily (0900 h, 2100 h) for the next 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
2011
Completed Phase 4
~4170
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,314 Total Patients Enrolled
23 Trials studying Methamphetamine Abuse
1,470 Patients Enrolled for Methamphetamine Abuse
University of California, Los AngelesLead Sponsor
1,554 Previous Clinical Trials
10,264,052 Total Patients Enrolled
8 Trials studying Methamphetamine Abuse
1,211 Patients Enrolled for Methamphetamine Abuse
Edythe D London, Ph.D.Principal InvestigatorUniversity of California, Los Angeles
2 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking medications that directly affect how dopamine works in your brain, like certain antipsychotic drugs.You are afraid of small, enclosed spaces.You have a metal device in your body, like a pacemaker or aneurysm clip.You have a diagnosed condition called stimulant-use disorder according to the DSM 5 guidelines.You have a heart condition or high blood pressure that is considered significant, as determined by a physical exam or an abnormal ECG. Additionally, if you are taking a medication called warfarin, you will not be able to participate.You have diabetes or use insulin to manage your blood sugar.You have asthma or are currently using certain medications for breathing problems.You had a bad reaction to varenicline in the past.You have a history of seizures or a brain injury where you lost consciousness for more than 30 minutes.You have tried to hurt yourself in the past or are currently thinking about hurting yourself.
Research Study Groups:
This trial has the following groups:- Group 1: Varenicline
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
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