Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03711318
Other study ID # 7699
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date November 1, 2018
Est. completion date December 31, 2021

Study information

Verified date November 2022
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. Individuals between the ages of 18-60 2. 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 3. Seeking treatment for opioid use disorder with Vivitrol 4. Capable of giving informed consent and complying with study procedures 5. In otherwise good health based on complete medical history and physical examination, laboratory tests, and EKG 6. BMI between 18-40 Exclusion Criteria: 1. Reported treatment with methadone in the last 3 months or positive urine toxicology for methadone on the day of consent 2. Maintenance on, or regular use of buprenorphine or other prescription opioids 3. Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods. 4. 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. 5. 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. 6. Physiologically dependent on alcohol or sedative- hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary. 7. History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam. 8. Chronic neurocognitive disorder 9. History of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received. 10. Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications 11. Fentanyl only use, supported by a urine toxicology that is positive for fentanyl only and negative for all other opioids. 12. Court mandated to treatment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Buprenorphine/naloxone
3 week treatment with buprenorphine/naloxone

Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol Number of patients who received the first Vivitrol injection among those who initiated the induction 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT00577408 - Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone Phase 3
Completed NCT00218309 - Effects of Pre-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals Phase 2
Completed NCT00000211 - Treatment Efficacy for Drug Abuse and AIDS Prevention - 2 Phase 2
Completed NCT00000210 - Treatment Efficacy for Drug Abuse and AIDS Prevention - 1 Phase 2
Completed NCT02324725 - Biomarkers of Injectable Extended Release Naltrexone Treatment Phase 4
Withdrawn NCT00000330 - Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-2 - 5 Phase 2
Completed NCT00249457 - Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 2 N/A
Completed NCT00218127 - Treatment of Opioid/Heroin Dependence: Comparison of Three Medication Dosing Regimens Phase 2
Completed NCT04133974 - Methadone Induced Memory Retrieval-extinction Procedure in Heroin Addicts N/A
Completed NCT00015288 - Buprenorphine and Naloxone Combination Study - 10 Phase 1
Recruiting NCT02541526 - Mirtazapine as a Treatment for Co-Occurring Opioid and ATS Dependence in Malaysia Phase 3
Active, not recruiting NCT02541513 - An Open-label Study of Oral Paliparidone for the Treatment of Patients With Co-occurring Opioid and ATS Dependence Phase 3
Completed NCT01760473 - Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone Phase 3
Terminated NCT01395797 - Pioglitazone for Heroin and for Nicotine Dependence Phase 1/Phase 2
Completed NCT01668706 - Pharmacogenomics Study of Sleep Disturbance and Neurocognitive Impairments in the Opioid Addicts N/A
Active, not recruiting NCT00609089 - Community Reinforcement and Family Training for Drug Abuse Treatment Retention/HIV Risk Reduction Phase 1/Phase 2
Completed NCT00684840 - Effects of Stress and Other Factors on Opiate Drug Choice. N/A
Completed NCT00759005 - Effect of Stress on Heroin-Related Memory Retrieval N/A
Completed NCT00218530 - Effectiveness of Naltrexone and Lofexidine in Treating Detoxified Heroin Addicts - 1 Phase 1
Completed NCT00158288 - The Efficacy of Methadyl Acetate (LAAM) and Contingency Management Procedures for Treating Dual Opioid and Cocaine Abuse - 1 Phase 2