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Opioid Partial Agonist
Injectable Buprenorphine for Methamphetamine Use Disorder (CTN-0110 Trial)
Phase 2
Waitlist Available
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
Must not have
Have a surgery planned or scheduled, or other treatment that would require the use of opioid-containing medications (e.g., opioid analgesics) during the study period;
If biologically female, be currently pregnant, breastfeeding, or planning on conception;
Timeline
Screening 7 days
Treatment 12 weeks
Follow Up 1 month
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am scheduled for surgery or treatment that will need opioid painkillers.
Select...
I am currently pregnant, breastfeeding, or planning to become pregnant.
Timeline
Screening ~ 7 days3 visits
Treatment ~ 12 weeks24 visits
Follow Up ~ 1 month1 visit
Screening ~ 7 days
Treatment ~ 12 weeks
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of MA-negative UDS results obtained
Secondary study objectives
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 moreTrial 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
10,825 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