Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT05283304
Eligibility Criteria:
Inclusion Criteria:
* Study participants must:
1. Be 18 to 65 years of age, inclusive;
2. Able to understand and speak English or Spanish
3. Be interested in reducing or stopping MA use;
4. Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for moderate or severe MUD (4 or more criteria);
5. Self-report MA use on 18 or more days in the 30-day period prior to written consent using the TLFB;
6. Provide at least 2 urine samples positive for MA out of a possible 3 tests to occur at clinic visits within a 10-day period with at least 2 days between visits;
7. Meet DSM-5 criteria for mild OUD (at least 2 but no more than 3 criteria) prior to randomization OR opioid misuse demonstrated by self-report of opioid use of at least 2 days in the 30-day period prior to written consent using the TLFB;
8. Provide a urine drug screen negative for opioids at least once during the screening period and on the day of expected randomization to indicate control over opioid use;
9. Have a Clinical Opiate Withdrawal Scale (COWS) score of ≤8 at both a screening visit on which they provide a UDS negative for opioids and on the day of randomization.
10. If female, agree to use acceptable methods of contraception and have periodic urine pregnancy testing during participation in the study unless unable to get pregnant;
11. Be willing and able to provide consent and comply with all study procedures and medication instructions.
Exclusion Criteria:
* Study participants must not:
1. Have suicidal or homicidal ideation that requires immediate attention;
2. Have evidence of prolongation of the corrected QT interval (QTc) or any other finding on the screening ECG that, in the opinion of the Medical Clinician, would preclude safe participation in the study (e.g., hypokalemia, unstable atrial fibrillation) and be at significant risk for serious cardiac adverse events;
3. Have a laboratory value with total bilirubin ≥1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) ≥3 × ULN, aspartate aminotransferase (AST) ≥5 × ULN, or serum creatinine \>2 × ULN;
4. Have been in a study of pharmacological or behavioral treatment for addiction within 6 months prior to written study consent (smoking cessation excepted);
5. Have taken an investigational drug in another study within 30 days prior to written study consent;
6. Have been prescribed and taken buprenorphine or methadone within 30 days prior to written study consent;
7. Be concurrently enrolled in formal behavioral or pharmacological addiction treatment services at the time of written consent;
8. Be receiving ongoing treatment of medications that are clinically relevant Cytochrome P450 3A4 (CYP 3A4) or Cytochrome P4502C8 (CYP 2C8) inducers or inhibitors (e.g., rifampicin, azole antifungals, macrolide antibiotics), Class IA antiarrhythmic medications (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone) at the time of randomization that, in the judgment of the Medical Clinician, could interact adversely with study medications or put them at significant risk for development of serotonin syndrome;
9. Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study as determined by the Medical Clinician;
10. 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;
11. Currently or soon to be in jail or prison; currently in any inpatient overnight facility as required by court of law or have pending legal action or other situation that could prevent participation in the study or in any study activities;
12. If biologically female, be currently pregnant, breastfeeding, or planning on conception;
13. Hypersensitivity (e.g., anaphylaxis) to buprenorphine or any component of the ATRIGEL formulation or their excipients;
14. Have an abdominal area unsuitable for subcutaneous injections by the judgment of the Medical Clinician;
15. Have other medical, psychiatric or other factors that in the judgment of the Medical Clinician could make participation difficult or unsafe.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05283304
Study Brief:
Protocol Section:
NCT05283304