Opioid-Related Disorders Clinical Trial
Official title:
Opiate Replacement Therapy at Release From Incarceration
Verified date | May 2009 |
Source | The Miriam Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
Much of the HIV/AIDS epidemic is driven by transmission from or to persons addicted to opiates. Many of these individuals pass through a correctional setting each year, creating an opportunity for linkage to substance abuse treatment. The purpose of this study was to evaluate the effectiveness of initiating opiate replacement therapy prior to release from incarceration on reducing HIV risk behaviors and drug relapse. In addition, this study evaluated the effectiveness of short-term payment versus non-payment of community opiate replacement therapy immediately following release from incarceration.
Status | Completed |
Enrollment | 87 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Currently incarcerated at the Rhode Island Department of Corrections with a scheduled release date at least 28 days after enrollment - Incarceration length not to have exceeded two years at the time of enrollment - Heroin dependent with self-reported heroin injection in the month prior to incarceration OR enrollment in a methadone treatment program prior to incarceration for heroin addiction with a history of injection drug use - Desire to enter methadone treatment upon release and plans to secure funding for methadone treatment after study completion - History of prior tolerance to methadone - History of at least one drug-related incarceration - Speaks English or Spanish - Plans to remain in Rhode Island for the duration of the study (24 months) - Ability to provide at least two names of individuals who can verify participant information Exclusion Criteria: - Currently receiving methadone at the Rhode Island Department of Corrections - Currently undergoing a non-narcotic detoxification from illicit opiates at the Rhode Island Department of Corrections - Plans to leave Rhode Island within the two years following enrollment |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | The Miriam Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
The Miriam Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment Engagement | Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome is measured by frequency - yes, participant attended initial clinic appointment within 30 days post release or no, participant did not attend clinic appointment within 30 days post release. Data source was methadone clinic chart review. | within 30 days post release of incarceration | No |
Primary | Time to MMT Initiation Post Release Based on Clinic Chart Review | Participants are considered to have successfully initiated community methadone maintenance treatment only if they make their first clinic appointment within 30 days after being released from incarceration. This outcome measures number of days from release to the first day of clinic attendance, only for those participants who successfully entered methadone treatment post release. Data source was methadone clinic chart review. | within 30 days post release from incarceration | No |
Primary | HIV Risk Behaviors - Self Report | Participants who self-reported injecting illicit drugs in the past 30 days, based on responses to face-to-face administration of the 6 month interview. | 6 month follow-up interviews | No |
Secondary | Drug Use | Participants who self-reported heroin use in the past 30 days, based on responses to face-to-face administration of the 6 month interview. | 6 month follow-up interviews | No |
Secondary | Fatal Overdose | Number of participants who died as the result of drug poisoning within six months of release of incarceration. This outcome was based on review of death records. | Within six months from release of incarceration | Yes |
Secondary | Non-fatal Overdose | Participants who self-reported experiencing an overdose within the past six months, based on responses to face-to-face administration of the 6 month interview. | 6 month follow-up interviews | Yes |
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 |
NCT00218309 -
Effects of Pre-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals
|
Phase 2 | |
Terminated |
NCT00000243 -
Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone
|
N/A | |
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 |
NCT00000306 -
Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3
|
Phase 2 | |
Completed |
NCT00000279 -
Novel Medications for Opiate Detoxification - 4
|
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 |