Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00000243
Other study ID # NIDA-08045-1
Secondary ID R01-08045-1DPMC
Status Terminated
Phase N/A
First received September 20, 1999
Last updated January 11, 2017
Start date September 2002
Est. completion date January 2004

Study information

Verified date November 2016
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone. The purpose of this study is to determine the effects of different doses of buprenorphine/naloxone in treating opioid dependent individuals who were previously maintained on methadone.


Description:

Buprenorphine is a mixed agonist-antagonist opioid that is being developed as a treatment for opioid dependence. Because buprenorphine is a partial mu agonist opioid, under certain conditions it is possible for buprenorphine to precipitate opioid withdrawal in opioid dependent individuals. A person with a high level of physical dependence could experience buprenorphine-related precipitated withdrawal. The purpose of this study is to test the acute effects of different doses of buprenorphine/naloxone in opioid dependent individuals maintained on methadone. The study is designed to provide dosing schedules similar to those that might be initially used in a physician's office.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date January 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Meets criteria for opioid dependence

Exclusion Criteria:

- Significant medical or psychiatric illness

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Buprenorphine


Locations

Country Name City State
United States Johns Hopkins University (BPRU) Bayview Campus Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physiological effects
Primary Analog rating scale for drug effects
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03950492 - Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder N/A
Completed NCT00000335 - Activity Monitoring Assessment of Opiate Withdrawal - 4 Phase 2
Active, not recruiting NCT03949764 - The Kentucky Viral Hepatitis Treatment Study Phase 4
Enrolling by invitation NCT06084221 - Fatal Overdose Review Teams - Research to Enhance Surveillance Systems N/A
Completed NCT02978417 - Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings Phase 4
Withdrawn NCT03137030 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults Phase 1
Withdrawn NCT03137017 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults Phase 1
Completed NCT02282306 - Phone Interview to Prevent Recurring Opioid Overdoses N/A
Completed NCT00710385 - Abuse Liability of Suboxone Versus Subutex Phase 3
Completed NCT00142935 - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1 N/A
Completed NCT00218309 - Effects of Pre-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals Phase 2
Completed NCT00067184 - Fetal Neurobehavioral Development in Methadone Maintained Pregnancies
Completed NCT00000264 - Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide - 16 N/A
Completed NCT00000257 - Effects of Alcohol History on Effects of Nitrous Oxide - 9 N/A
Completed NCT00000279 - Novel Medications for Opiate Detoxification - 4 Phase 2
Completed NCT00000306 - Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3 Phase 2
Completed NCT00000249 - Effects of Subanesthetic Concentrations of Nitrous Oxide - 1 Phase 2
Recruiting NCT04933084 - Pre-operative Education Modalities to Decrease Opioid Use N/A
Recruiting NCT03610672 - Mobile Intervention for Young Opioid Users N/A
Terminated NCT02741076 - Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain Phase 4