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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA013636 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of the study is to determine whether one of three levels of counseling intensity will be associated with better treatment outcomes when combined with methadone maintenance treatment for heroin-addicted adults drawn from a methadone treatment program waiting list.
Waiting lists for methadone treatment programs persist, and new and more effective approaches for expanding treatment access and improving outcomes for heroin dependent individuals are needed. Recently completed research demonstrated that so-called "Interim Methadone Maintenance" (i.e., methadone with crisis counseling only, for individuals on waiting lists) was associated with greater entry into methadone treatment, less self-reported heroin and cocaine use, lower rates of opioid-positive drug tests, and lower rates of self-reported crime. The present study will build on this work by comparing three levels of counseling provided with methadone treatment: 1)"Interim" Methadone Treatment; 2) "Comprehensive" Methadone Treatment (which is the name for the usual amount of counseling provided, i.e., about once per week) and; 3)"Restored" Methadone Treatment in which the counselors will have a lower case load and will be able to provide more attention to their patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interim | Active Comparator | Methadone maintenance for up to 4 months with emergency counseling only for individuals on program waiting lists. |
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| Comprehensive | Active Comparator | Methadone Treatment provided with counseling as usual. |
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| Restored | Active Comparator | Methadone Treatment with counseling provided by a clinician with a lower caseload than counseling as usual. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interim | Behavioral | Methadone maintenance with emergency counseling only for up to 4 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid positive drug tests | 4 and 12 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| HIV risk behavior | 4 and 12 months post-baseline | |
| Treatment Retention | 4 and 12 months post-baselin | |
| Cost-benefit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert P Schwartz, M.D. | Friends Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friends Research Institute | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16793221 | Background | Schwartz RP, Jaffe JH, Highfield DA, Callaman JM, O'Grady KE. A randomized controlled trial of interim methadone maintenance: 10-Month follow-up. Drug Alcohol Depend. 2007 Jan 5;86(1):30-6. doi: 10.1016/j.drugalcdep.2006.04.017. Epub 2006 Jun 21. | |
| 16389204 | Background | Schwartz RP, Highfield DA, Jaffe JH, Brady JV, Butler CB, Rouse CO, Callaman JM, O'Grady KE, Battjes RJ. A randomized controlled trial of interim methadone maintenance. Arch Gen Psychiatry. 2006 Jan;63(1):102-9. doi: 10.1001/archpsyc.63.1.102. |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D006556 | Heroin Dependence |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003833 | Denture, Partial, Temporary |
| ID | Term |
|---|---|
| D003829 | Denture, Partial |
| D003778 | Dentures |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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| Comprehensive |
| Behavioral |
Methadone treatment with counseling as usual |
|
| Restored | Behavioral | Methadone maintenance with counseling provided by a clinician with a lower than usual caseload |
|
| 12 months post-baseline |
| Cocaine positive tests | 4 and 12 months post-baseline |
| 17784892 | Background | Highfield DA, Schwartz RP, Jaffe JH, O'Grady KE. Intravenous and intranasal heroin-dependent treatment-seekers: characteristics and treatment outcome. Addiction. 2007 Nov;102(11):1816-23. doi: 10.1111/j.1360-0443.2007.01998.x. Epub 2007 Sep 3. |
| 21353445 | Background | Schwartz RP, Kelly SM, O'Grady KE, Gandhi D, Jaffe JH. Interim methadone treatment compared to standard methadone treatment: 4-month findings. J Subst Abuse Treat. 2011 Jul;41(1):21-9. doi: 10.1016/j.jsat.2011.01.008. Epub 2011 Feb 24. |
| 24239030 | Result | Schwartz RP, Alexandre PK, Kelly SM, O'Grady KE, Gryczynski J, Jaffe JH. Interim versus standard methadone treatment: a benefit-cost analysis. J Subst Abuse Treat. 2014 Mar;46(3):306-14. doi: 10.1016/j.jsat.2013.10.003. Epub 2013 Oct 14. |
| 22029398 | Result | Schwartz RP, Kelly SM, O'Grady KE, Gandhi D, Jaffe JH. Randomized trial of standard methadone treatment compared to initiating methadone without counseling: 12-month findings. Addiction. 2012 May;107(5):943-52. doi: 10.1111/j.1360-0443.2011.03700.x. Epub 2012 Feb 11. |
| 22134175 | Result | Kelly SM, Schwartz RP, O'grady KE, Gandhi D, Jaffe JH. Impact of methadone with versus without drug abuse counseling on HIV risk: 4- and 12-month findings from a clinical trial. J Addict Med. 2012 Jun;6(2):145-52. doi: 10.1097/ADM.0b013e31823ae556. |
| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |