The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence
Opioid Dependence
About this trial
This is an interventional treatment trial for Opioid Dependence focused on measuring opioid use disorder, treatment, heroin, extended-release naltrexone, incentives, cotningency management, employment-based reinforcement, therapeutic workplace
Eligibility Criteria
Inclusion Criteria:
- meet the DSM-IV criteria for opioid dependence,
- report using heroin at least 21 of the last 30 days while living in the community,
- are unemployed,
- are 18-65 years old,
- are medically approved for naltrexone,
- live in or near Baltimore, MD.
Exclusion Criteria:
- have current DSM-IV major Axis I disorders
- have current suicidal or homicidal ideation
- express interest in methadone treatment
- are required to use opioids for medical purposes
- earned over $200 in taxable income over the previous 30 days while living in the community
- have physical limitations that prevent them from using a keyboard
- are pregnant or breastfeeding
- have serum aminotransferase levels over three times normal
- have known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or poly (lactide-co-glycolide) (PLG) or any other components of the diluents;
- are participating in any other clinical study.
Sites / Locations
- Johns Hopkins Bayview Center for Learning and Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Other
Vivitrol Only
VIVITROL&Opiate Abstinence Reinforcement
Opiate Abstinence Reinforcement Only
Usual Care Control
The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.
This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.
This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.