The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence

Phase 2

Completed

Conditions: Opioid Dependence

Interventions: Other: Usual Care Control
Drug: Vivitrol
Behavioral: Employment-based opiate abstinence reinforcement

Registration Number: NCT01556425

Lead Sponsor: Johns Hopkins University

Brief Summary: In this 5-year study, the investigators propose to evaluate the separate and combined effects of the FDA-approved formulation of extended release naltrexone (Vivitrol®) and employment-based reinforcement of opiate abstinence in promoting opiate abstinence and reducing risky injection behavior in recently detoxified, opioid-dependent, injection drug users.

Detailed Description: Injection heroin use is a chronic problem that fuels the transmission of HIV/AIDS through risky injection behaviors. Methadone and buprenorphine can reduce heroin use and risky injection behavior; however, they have abuse potential, produce physical dependence, can produce lethal overdose, are highly regulated, and some patients simply do not want agonist treatment. Opiate detoxifications can serve as an alternative to agonist treatment, but many injection drug users relapse to heroin use and resume risky injection behaviors after detoxification. Vivitrol®, an extended release formulation of naltrexone, was recently approved by the FDA for the treatment of opioid dependence, but its clinical utility is uncertain given the reluctance of many opioid-dependent adults to maintain its long-term use, and the fact that some patients continue to use opiates while under naltrexone blockade. The investigators research in the first period of this grant showed that employment-based reinforcement can be highly effective in promoting long-term adherence to Vivitrol®. Employment-based reinforcement may be ideally suited to address the limitations of extended release naltrexone by capitalizing on its potential to simultaneously reinforce naltrexone adherence and opiate abstinence. This grant will evaluate the effectiveness of employment-based reinforcement to simultaneously promote high rates of Vivitrol® adherence and increase opiate abstinence. After an opioid detoxification and induction onto oral naltrexone, participants will be invited to attend the Therapeutic Workplace for 24 weeks (where they can work and earn wages) and will be randomly assigned to one of four groups that will differ in whether they receive Vivitrol®, employment-based opiate abstinence reinforcement, both or neither. Participants in Vivitrol® conditions will be required to take scheduled injections to work and earn wages. Participants exposed to opiate abstinence reinforcement will receive a temporary decrease in their workplace pay if they fail to provide an opiate-free urine sample. The study will assess the effects of the interventions on weekly opiate urinalysis results, and on measures of injection drug use and cocaine use. If this study shows that the combined use of Vivitrol® and employment-based reinforcement of adherence and opiate abstinence is effective in maintaining long-term opiate abstinence, this model of employment-based addiction pharmacotherapy could be integrated into community workplaces to disseminate the effective use of Vivitrol®; it could be used to enhance the utility of other new antagonist-like addiction medications; and it could provide an effective means of reducing injection drug use in individuals who persist in injecting heroin and exposing themselves and others to the risk of acquiring or transmitting HIV infection due to their continued injection drug use and risky injection behaviors.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 84

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIVITROL&Opiate Abstinence Reinforcement	Employment-based opiate abstinence reinforcement	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.
Opiate Abstinence Reinforcement Only	Employment-based opiate abstinence reinforcement	This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.
Usual Care Control	Usual Care Control	This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.
Vivitrol Only	Vivitrol	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.
VIVITROL&Opiate Abstinence Reinforcement	Vivitrol	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.

Primary Outcome Measures

Name	Time	Method
Percent of Weekly Urine Samples Negative for Opiates	24 weeks	Was the participant's urine sample negative for opiates at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for opiates.

Secondary Outcome Measures

Name	Time	Method
Percent of Weekly Urine Samples Negative for Cocaine	24 weeks	Was the participant's urine sample negative for cocaine at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for cocaine.