Your session is about to expire
← Back to Search
Stimulant
Mirtazapine for Methamphetamine Addiction
Phase 1
Recruiting
Led By Phillip Coffin, MD, MIA
Research Sponsored by San Francisco Department of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-55 years inclusive
age 18-55 years inclusive;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 days
Awards & highlights
Study Summary
This trial will study the effects of the drug mirtazapine on methamphetamine users. It will test if the drug alters the cardiovascular response or the pharmacokinetics of methamphetamine. The trial will also study if these effects are different in methamphetamine users who also use opioids.
Who is the study for?
This study is for English-speaking adults aged 18-55 with methamphetamine use disorder, not seeking treatment for it. Participants must have a stable heart rate and blood pressure, normal EKG results, and no serious health issues. Women must not be pregnant or breastfeeding and agree to birth control measures. People using opioids can join if on methadone but not other drugs.Check my eligibility
What is being tested?
The trial tests how mirtazapine affects the body's response to injected methamphetamine (MA), including changes in cardiovascular reactions and MA levels in the blood. It also examines these effects when used alongside methadone maintenance therapy in two groups of participants who are active MA users.See study design
What are the potential side effects?
Potential side effects may include changes in heart rate or blood pressure due to drug interactions between mirtazapine and methamphetamine. Other risks could involve typical responses to either substance such as fatigue, confusion, digestive upset, mood swings, or more severe cardiovascular events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
Select...
I am between 18 and 55 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Metabolism of methamphetamine in presence of steady state mirtazapine
Safety Measures
Secondary outcome measures
Impact of mirtazapine on discounting in the presence of methamphetamine
Impact of mirtazapine on mood produced by methamphetamine use
Impact of mirtazapine on subjective effects of methamphetamine reinforcement
+2 moreSide effects data
From 2014 Phase 4 trial • 38 Patients • NCT0117867144%
nausea
43%
sexual dysfunction (men)
43%
decreased libido (men)
33%
fatigue
28%
somnolence
28%
dry mouth
28%
constipation
28%
decreased appetite
28%
sweating
28%
urinary dysfunction
28%
diarrhea
28%
tremor
27%
decreased libido (women)
22%
lightheadedness
22%
forgetfulness
22%
impaired concentration
18%
sexual dysfunction (women)
17%
apathy
17%
heartburn
17%
emesis
17%
headache
11%
incoordination
11%
blurry vision
11%
increased appetite
11%
insomnia
6%
nervousness
6%
skin problems
6%
bruising
6%
restlessness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sertraline and Sugar Pill
Sertraline and Mirtazapine
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MirtazapineExperimental Treatment2 Interventions
Mirtazapine 30 mg PO daily x 4 days
Group II: PlaceboPlacebo Group1 Intervention
Placebo 30 mg PO Daily x 4 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirtazapine
FDA approved
Metamfetamine
FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
San Francisco Department of Public HealthLead Sponsor
35 Previous Clinical Trials
34,327 Total Patients Enrolled
University of California, Los AngelesOTHER
1,530 Previous Clinical Trials
10,264,684 Total Patients Enrolled
Phillip Coffin, MD, MIAPrincipal Investigator - Director, Substance Use Division, San Francisco Department of Public Health
San Francisco Department of Public Health
2 Previous Clinical Trials
163 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical activity must be normal, and a specific measurement of your heart's rhythm should be within a certain range.Your liver and kidney function tests must be within normal limits.I am between 18 and 55 years old.I am not pregnant or breastfeeding and agree to use birth control during and after the trial.I do not have any untreated serious illnesses like autoimmune or infectious diseases.I am not pregnant or breastfeeding and will use birth control during and after the trial.I have a history of seizures.You must be diagnosed with a specific type of substance use disorder called MA use disorder using a specific diagnostic tool.You have been diagnosed with a substance use disorder related to methamphetamine.You must be looking for help with substance abuse issues during the study.You currently have a problem with using cocaine, cannabis, or alcohol, according to a specific set of guidelines used by doctors.Your blood pressure should be between 100/45 and 150/90 two days before starting the study.Your urine must test positive for specific drugs and negative for alcohol.You have tried to harm yourself in the past 90 days or currently have thoughts or plans to harm yourself.You need to have a positive test for MA in your urine during the screening.I am currently taking medication for mental health or seizures.You have been diagnosed with a substance use disorder related to methamphetamine.Your heart rate at rest is between 50 and 90 beats per minute.I am between 18 and 55 years old.You have tested positive for drugs in your urine during screening.Your heart beats at a rate between 50 and 90 beats per minute when you are resting.I haven't had severe side effects from a test dose of medication.You have had a bad reaction to this medication before, like chest pain or a seizure.Your heart rate at rest should be between 50 and 90 beats per minute.If you are taking methadone for opioid addiction, your urine test should show positive for methadone and negative for buprenorphine when you join the study.You do not have severe mental illnesses like schizophrenia or bipolar disorder, except for stable major depressive disorder or generalized anxiety disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Mirtazapine
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Drug Interaction Patient Testimony for trial: Trial Name: NCT04614584 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Mirtazapine for therapeutic applications?
"Given that it is a Phase 1 trial, the safety of mirtazapine has been assessed at level one on the scale due to limited evidence in terms of both efficacy and security."
Answered by AI
What beneficial outcomes is the trial hoping to achieve?
"This 24-day medical trial focuses on the biotransformation of methamphetamine in tandem with steady state mirtazapine. Additionally, secondary objectives include evaluating the impact of mirtazapine use on mood (via Addiction Research Inventory short form), preference for methamphetamine when combined with mirtazapine (measured by Drug Purchase Task) and reactions to reinforced stimulant effects from methamphetamine usage (Subjective Effects Questionnaire)."
Answered by AI
Is this particular research endeavor currently looking for participants?
"That is correct. According to information from clinicaltrials.gov, this medical research initiative was uploaded on July 12th 2021 and last updated August 16th 2021. The trial requires 24 individuals for participation across 3 distinct healthcare facilities."
Answered by AI
What clinical indications is Mirtazapine typically employed to address?
"Mirtazapine is a common medication used to treat attention deficit hyperactivity disorder (ADHD). However, its applications are not limited to this diagnosis as it can also be beneficial for managing panic attacks, major depressive disorder (MDD), and poststroke depression."
Answered by AI
Are there any previous experiments that have utilized Mirtazapine?
"Currently, 12 clinical trials are underway looking into the efficacy of Mirtazapine with 2 studies in their final phases. These medical evaluations span 35 different sites, many situated within Orange County, California."
Answered by AI
What is the uppermost threshold of participants enrolled in this experiment?
"Affirmative, the clinicaltrials.gov app indicates that this trial is presently recruiting participants. The study was first listed on July 12th 2021 and has been revised recently on August 16th 2021. 24 individuals are required from 3 medical centres for participation in the experiment."
Answered by AI
Who else is applying?
What state do they live in?
California
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
What site did they apply to?
UCLA Medical Center
San Francisco Department of Public Health
Why did patients apply to this trial?
I take different medication and I am interested in the trial about drug interactions.
PatientReceived 2+ prior treatments
I am totally incapable of staying sober from amphetamines and a drug that could potentially help with the problem is of paramount importance to me .
PatientReceived 2+ prior treatments
I am not sure because in all honesty I have severe ADHD and I think Meth actually helps me and calms me more than anything. I just wish there was a cleaner, legal, non harmful version of it. It boosts my mood, it gives me more energy, I can concentrate on it, when you meet me you will never know I am on it. I've done it for years now and no one has the slightest idea. It literally helps me in every avenue of my life but I know it's not good for you so I don't know.
PatientReceived 2+ prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger