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Opioid Partial Agonist
Injectable Buprenorphine for Methamphetamine Use Disorder (CTN-0110 Trial)
Phase 2
Recruiting
Led By Madhukar Trivedi, MD
Research Sponsored by Madhukar H. Trivedi, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be 18 to 65 years of age, inclusive;
Able to understand and speak English or Spanish
Timeline
Screening 7 days
Treatment 12 weeks
Follow Up 1 months
Awards & highlights
CTN-0110 Trial Summary
This trial tests if a medication can help with Meth use disorder, with mild opioid use.
Who is the study for?
This trial is for adults aged 18-65 with methamphetamine use disorder and mild opioid use, who want to reduce or stop using methamphetamine. Participants must speak English or Spanish, not be on certain medications, have no severe liver or kidney issues, and women must agree to contraception and pregnancy testing.Check my eligibility
What is being tested?
The study compares a monthly injectable buprenorphine (BUP-Inj) against a placebo injection over 12 weeks in individuals with methamphetamine abuse/addiction and mild co-use of opioids. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real medicine.See study design
What are the potential side effects?
Possible side effects of BUP-Inj may include reactions at the injection site, nausea, headache, dizziness, fatigue or allergic reactions like anaphylaxis. The severity can vary from person to person.
CTN-0110 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I can understand and speak English or Spanish.
Select...
I have passed a drug test for opioids during screening and on the day I expect to join the trial.
CTN-0110 Trial Timeline
Screening ~ 7 days3 visits
Treatment ~ 12 weeks24 visits
Follow Up ~ 1 months1 visit
Screening ~ 7 days
Treatment ~ 12 weeks
Follow Up ~1 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of MA-negative UDS results obtained
Secondary outcome measures
Number of days of MA and opioid co-use during the medication phase
Number of days of methamphetamine use during the medication phase
Number of days of opioid use during the medication phase
+3 moreCTN-0110 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Injectable Buprenorphine (BUP-inj)Experimental Treatment1 Intervention
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable buprenorphine (300 mg dose) every 4 weeks
Group II: Injectable Placebo (PBO-inj)Placebo Group1 Intervention
Following successful titration to 16 mg of daily sublingual buprenorphine, the participants will then transition to injectable placebo (300 mg dose) every 4 weeks.
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Madhukar H. Trivedi, MDLead Sponsor
Madhukar Trivedi, MDPrincipal InvestigatorUT Southwestern Medical Center
14 Previous Clinical Trials
10,830 Total Patients Enrolled
1 Trials studying Methamphetamine Abuse
129 Patients Enrolled for Methamphetamine Abuse
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have passed a drug test for opioids during screening and on the day I expect to join the trial.I am scheduled for surgery or treatment that will need opioid painkillers.You have recently used opioids for at least two days in the past month or you have met 2-3 criteria for mild opioid use disorder (OUD) according to the DSM-5.You have participated in a drug or behavior addiction study within 6 months before agreeing to this study (except for smoking cessation).My doctor says my belly area isn't good for needle shots.I have taken buprenorphine or methadone in the last 30 days.I am not on any medication that could badly interact with the study drugs.I meet the specific requirements to participate in the study.People who cannot participate in the study:I can understand and speak English or Spanish.I agree to use birth control and undergo pregnancy tests if I can get pregnant.I am between 18 and 65 years old.You have participated in another study involving an experimental drug within 30 days before agreeing to participate in this study.I am currently pregnant, breastfeeding, or planning to become pregnant.You meet the criteria for moderate or severe MUD, which is determined by specific guidelines called DSM-5.I want to reduce or stop using methamphetamine.You have thoughts of harming yourself or others that require immediate help.You have other health or mental conditions that could make it hard or unsafe for you to participate, according to the medical clinician's judgment.
Research Study Groups:
This trial has the following groups:- Group 1: Injectable Buprenorphine (BUP-inj)
- Group 2: Injectable Placebo (PBO-inj)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 7 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
Methamphetamine Abuse Patient Testimony for trial: Trial Name: NCT05283304 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the current protocol permit seniors aged 75 and above to participate?
"This clinical trial is seeking participants whose age falls within the parameters of 18 years or older, and 65 years old or younger."
Answered by AI
Has the Federal Drug Administration sanctioned Injectable Buprenorphine (BUP-inj) for medical use?
"The safety of BUP-inj is rated a 2 on our internal scale, as the clinical trial currently being conducted is only in its second phase. This indicates that while some data has been collected regarding it's safety, none exists yet to support efficacy."
Answered by AI
Are enrollees being accepted to participate in this clinical investigation at present?
"Affirmative. Clinicaltrials.gov reports that the trial, which was first uploaded on March 1st 2023 and last modified on March 3rd of the same year, is actively recruiting patients. 246 volunteers need to be sourced from a single location for this research project."
Answered by AI
To what extent is the cohort of this medical study being assessed?
"Affirmative. Clinicaltrials.gov hosts information that confirms the commencement of this clinical trial on March 1st, 2023 and its subsequent updates to recruit 246 participants from one medical centre."
Answered by AI
How can I take part in this research project?
"This clinical trial is recruiting 246 individuals aged 18 to 65 with methamphetamine addiction. To be eligible, they must meet the following criteria: Be fluent in English or Spanish; Display signs of moderate-severe MUD (4+ DSM-5 Criteria); Report MA use on at least 18 days within the last 30 days before written consent; Provide 2 out of 3 positive urine samples for MA over 10 day period; Have mild OUD/evidence of opioid misuse via self report and UDS tests OR have a COWS score ≤8 at screening and randomization visits; Females must agree to contraceptive measures & periodic pregnancy testing unless unable to bear children"
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
Texas
California
What site did they apply to?
UTSW Medical Center, Center for Depression Research and Clinical Care
Highland Hospital, Alameda Health System
Other
UCLA Vine Street Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
What questions have other patients asked about this trial?
How long is the screening visits and is there compensation?
PatientReceived no prior treatments
Why did patients apply to this trial?
I want to quit using. A desire to stop using. I struggle with Meth addiction.
PatientReceived no prior treatments
Want to stop methamphetamines abuse. Interested in the treatment plan you have to offer.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- UCLA Vine Street Clinic: < 24 hours
Average response time
- < 2 Days
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