Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals (NCT03711318) | Clinical Trial Compass
TerminatedPhase 3
Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals
Stopped: continuing study was no longer feasible
United States8 participantsStarted 2018-11-01
Plain-language summary
A short-term treatment with buprenorphine prior to initiating treatment with naltrexone may increase the proportion of heroin-dependent patients successfully inducted onto Vivitrol.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Individuals between the ages of 18-60
✓. Meets DSM-5 criteria of current opioid use disorder with six consecutive months of reported heroin use, supported by a positive urine for opiates indicating regular use of heroin
✓. Seeking treatment for opioid use disorder with Vivitrol
✓. Capable of giving informed consent and complying with study procedures
✓. In otherwise good health based on complete medical history and physical examination, laboratory tests, and EKG
✓. BMI between 18-40
Exclusion criteria
✕. Reported treatment with methadone in the last 3 months or positive urine toxicology for methadone on the day of consent
✕. Maintenance on, or regular use of buprenorphine or other prescription opioids
✕. Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
✕. Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with AST or ALT \> 3 times normal, AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection), unstable diabetes, cardiovascular disease.
✕. Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-5 Schizophrenia or any psychotic disorder, severe Major Depressive Disorder, or suicide risk or 1 or more suicide attempts within the past year.
What they're measuring
1
Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol