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| ID | Type | Description | Link |
|---|---|---|---|
| R01-DA018641-1 | |||
| DPMC | |||
| R01DA018641 | U.S. NIH Grant/Contract | View source |
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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.
A substantial proportion of individuals addicted to heroin are incarcerated while addicted and a majority of individuals released from a correctional setting have a history of heroin addiction. The period immediately after release from incarceration is a particularly high-risk time for HIV transmission and other problems, including drug relapse and overdose. Methadone treatment is the most widely used opiate replacement therapy in the United States and has been shown to decrease HIV risk, as well as drug use, addiction relapse, and criminal activity. 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.
Participants in this were randomly assigned to 1 of 3 treatment groups. Participants enrolled in Group 1 initiated methadone opiate replacement therapy about 1 month prior to release from incarceration. They proceeded with a methadone program of their choice upon release and received short-term payment to cover treatment costs. Participants enrolled in Group 2 were referred to a methadone program of their choice and received short-term payment to cover treatment costs. Participants enrolled in Group 3 were referred to a program of choice upon release from incarceration without receiving financial assistance. All participants had the opportunity to partake in existing support programs available at the Rhode Island Department of Corrections while incarcerated and in the community upon release. Follow-up assessments occurred at Months 1.5, 6, and 12. These included interviews and urine specimens for toxicology analysis to verify self-reports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Release Initiation MMT | Experimental | Participants assigned to this arm will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks. |
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| Post Release Initiation of MMT | Experimental | Participants assigned to this arm will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks. |
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| Standard of Care Plus | Active Comparator | Participants assigned to this arem will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-release Initiation of MMT | Behavioral | Participants assigned to arm 1 will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Fatal Overdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josiah D Rich, M.P.H., M.D. | The Miriam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
There were no significant events following participant enrollment and prior to group assignment.
All recruitment occurred at the Rhode Island Department of Corrections. Screening began on 9/15/2006 and the first participant was enrolled on 9/29/2006. The last participant was enrolled on 2/20/2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-release MMT Initiation + Referral Post Release + Payment | Participants assigned to this arm will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Post Release Initiation of MMT. | Behavioral | Participants assigned to Arm 2 will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks. |
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| Standard of Care Plus | Behavioral | Participants assigned to Arm 3 will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT. |
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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 |
| 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 |
| FG001 | MMT Referral Post Release + Payment | Participants assigned to this arm will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks. |
| FG002 | MMT Referral Post Release | Participants assigned to this arm will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with Medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-release MMT Initiation + Referral Post Release + Payment | Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs. |
| BG001 | MMT Referral Post Release + Payment | Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs. |
| BG002 | MMT Referral Post Release | Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | We assessed community methadone treatment clinic attendance of all enrolled participants based on clinic chart review. | Posted | Number | participants | within 30 days post release of incarceration |
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| 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. | Participants were analyzed as randomized (intent to treat). We calculated the mean number of days (and SD) between release from incarceration and first MMT clinic visit post release. Not all participants attended clinic within 30 days post release - those participants are not included in this analysis. | Posted | Mean | Standard Deviation | days | within 30 days post release from incarceration |
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| 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. | Posted | Number | participants | 6 month follow-up interviews |
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| 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. | Posted | Number | participants | 6 month follow-up interviews |
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| 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. | Posted | Number | participants | Within six months from release of incarceration |
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| 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. | Posted | Number | participants | 6 month follow-up interviews |
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12 months
Fatal Overdoses
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | As Assigned: Pre-release MMT + Referral Post Release + Payment | Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs. Fatal overdose deaths are calculated using all participants assigned to Arm 1. Other adverse events are calculated using self reported data from 12 month interviews. | 0 | 29 | 10 | 26 | ||
| EG001 | As Assigned: MMT Referral Post Release + Payment | Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs. Fatal overdose deaths are calculated using all participants assigned to Arm 2. Other adverse events are calculated using self reported data from 12 month interviews. | 2 | 28 | 8 | 20 | ||
| EG002 | As Assigned: MMT Referral Post Release | Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance. Fatal overdose deaths are calculated using all participants assigned to Arm 3. Other adverse events are calculated using self reported data from 12 month interviews. | 1 | 30 | 8 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatal Overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-fatal Overdose | Injury, poisoning and procedural complications | Systematic Assessment | Any overdose reported by participants in the 12 month post release interview. These were not related to participation in the study. |
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| ER visits | Injury, poisoning and procedural complications | Systematic Assessment | Any ER visits that were reported by participants in the 12 month post release interview. These were not related to participation in the study. |
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| Hospitalizations | Injury, poisoning and procedural complications | Systematic Assessment | Any hospitalizations that were reported by participants in the 12 month post release interview. These were not related to participation in the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josiah D. Rich, MD, MPH | The Miriam Hospital/Brown University | 401-793-4770 | jrich@lifespan.org |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| OG002 | As Assigned: MMT Referral Post Release | Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance. |
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