Project FIRST - Financial Incentives to Reduce Substance Use and Improve Treatment (Project FIRST)
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ClinicalTrials.gov Identifier: NCT01376570 |
Recruitment Status
:
Completed
First Posted
: June 20, 2011
Last Update Posted
: April 20, 2018
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Condition or disease | Intervention/treatment | Phase |
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HIV Opiate Dependence | Behavioral: Abstinence-reinforcing contingency management intervention Behavioral: Performance Feedback intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 242 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Trial of an Abstinence-reinforcing Contingency Management Intervention to Suppress HIV Viral Load |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | August 10, 2017 |
Actual Study Completion Date : | August 10, 2017 |

Arm | Intervention/treatment |
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Experimental: Contingency Management arm
The Contingency Management arm will receive the abstinence-reinforcing contingency management intervention.
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Behavioral: Abstinence-reinforcing contingency management intervention
The contingency management intervention consists of participants receiving vouchers exchangeable for goods and services contingent on achieving abstinence. When participants are abstinent (urine is free of cocaine, oxycodone and opiates), they will receive a voucher. If participants are not abstinent (cocaine or oxycodone or opiates are in the urine), they will not receive a voucher. The value of vouchers increases with continued evidence of abstinence. When participants have urines with opiates or cocaine, the value of the voucher is reset. The vouchers are part of the intervention, they are not participant compensation.
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Active Comparator: Control arm
The Control arm will receive the performance feedback intervention.
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Behavioral: Performance Feedback intervention
Participants will receive performance feedback about their drug use. The research team will provide informational slips of paper indicating results of urine tests and will congratulate participants when urines are drug-free or encourage participants to stop using cocaine and/or opiates when urines are not drug-free.
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- HIV viral load [ Time Frame: Viral load will be measured every 4 weeks over the 28-week follow-up period. ]Every 4 weeks participants will undergo phlebotomy to measure HIV viral load. Viral load will be analyzed as a continuous measure (log10 copies/ml). In secondary analyses, viral load will be analyzed dichotomously, as undetectable (<45 copies/ml) or not.
- CD4 count [ Time Frame: CD4 count will be measured at weeks 0, 4, 20, and 28. ]At weeks 0, 4, 20, and 28, participants will undergo phlebotomy and CD4 count will be measured. CD4 count will be analyzed as a continuous measure and an increase of 50 cells/mm3 will be considered a clinically significant improvement.
- Abstinence from opiates, oxycodone, and cocaine [ Time Frame: Abstinence will be measured twice weekly during weeks 0-20, then every two weeks during weeks 21-28. ]Participants will provide urine samples twice weekly during weeks 0-20, and every two weeks during weeks 21-28. Abstinence will be defined as having drug-free urine (no cocaine, oxycodone and opiates). Abstinence will be examined two different ways—as the proportion of drug-free urines and the number of consecutive drug-free urines. Although urine toxicology tests will be our primary data source for measuring abstinence, we will also measure addiction severity using the Addiction Severity Index.
- Antiretroviral adherence [ Time Frame: Antiretroviral adherence will be measured every 4 weeks during the 28-week follow-up period ]Antiretroviral adherence will be measured using pill counts. Adherence will be analyzed as a continuous measure, defined as the proportion of pills taken (# pills taken / # pills prescribed). Mean adherence over each 4-week period will be examined. In addition, we will also analyze adherence as a dichotomous measure (e.g., perfect [100%] adherence or not during each 4-week period).

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- at least 18 years old
- English or Spanish fluency
- HIV-infected
- Currently taking highly active antiretroviral therapy
- a) opioid use disorder and receiving opioid agonist treatment with methadone or buprenorphine, or b) cocaine use disorder
- urine toxicology positive for cocaine, oxycodone, or opioids during the run-in period
- detectable viral load while prescribed highly active antiretroviral therapy in the prior 6 months
- self-reported adherence to HAART <100%
Exclusion Criteria:
- inability to give informed consent
- inability to follow the research protocol (e.g., visits twice weekly)
- frequent hospitalizations (>2) in the prior 6 months
- currently with a chronic pain condition in which the participant has been prescribed opioid analgesics for longer than the past month

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376570
United States, New York | |
Montefiore's Community Clinics (Montefiore Medical Group) | |
Bronx, New York, United States, 10451 | |
Albert Einstein College of Medicine Division of Substance Abuse clinics | |
Bronx, New York, United States, 10461 | |
Montefiore Infectious Disease Clinic | |
Bronx, New York, United States, 10467 |
Principal Investigator: | Chinazo Cunningham, MD,MS | Albert Einstein College of Medicine, Inc. |
Responsible Party: | Chinazo Cunningham, Associate Professor of Medicine, Albert Einstein College of Medicine, Inc. |
ClinicalTrials.gov Identifier: | NCT01376570 History of Changes |
Other Study ID Numbers: |
2010-553 R01DA032110 ( U.S. NIH Grant/Contract ) |
First Posted: | June 20, 2011 Key Record Dates |
Last Update Posted: | April 20, 2018 |
Last Verified: | April 2018 |
Keywords provided by Chinazo Cunningham, Albert Einstein College of Medicine, Inc.:
HIV Opiate dependence Opiate replacement therapy Cocaine-related disorders |
Risk Reduction Behavior Medication Adherence Motivation |
Additional relevant MeSH terms:
Opioid-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Cocaine Opiate Alkaloids Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents |
Peripheral Nervous System Agents Vasoconstrictor Agents Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Analgesics, Opioid Narcotics Analgesics |