Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01556425
Other study ID # NA_00052254
Secondary ID 2R01DA019497-06
Status Completed
Phase Phase 2
First received March 5, 2012
Last updated February 13, 2018
Start date May 2012
Est. completion date August 6, 2017

Study information

Verified date February 2018
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 84
Est. completion date August 6, 2017
Est. primary completion date December 12, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. meet the DSM-IV criteria for opioid dependence,

2. report using heroin at least 21 of the last 30 days while living in the community,

3. are unemployed,

4. are 18-65 years old,

5. are medically approved for naltrexone,

6. live in or near Baltimore, MD.

Exclusion Criteria:

1. have current DSM-IV major Axis I disorders

2. have current suicidal or homicidal ideation

3. express interest in methadone treatment

4. are required to use opioids for medical purposes

5. earned over $200 in taxable income over the previous 30 days while living in the community

6. have physical limitations that prevent them from using a keyboard

7. are pregnant or breastfeeding

8. have serum aminotransferase levels over three times normal

9. have known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or poly (lactide-co-glycolide) (PLG) or any other components of the diluents;

10. are participating in any other clinical study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vivitrol
Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.
Behavioral:
Employment-based opiate abstinence reinforcement
This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant 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.
Other:
Usual Care Control
Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling.

Locations

Country Name City State
United States Johns Hopkins Bayview Center for Learning and Health Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of Weekly Urine Samples Negative for Opiates 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. 24 weeks
Secondary Percent of Weekly Urine Samples Negative for Cocaine 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. 24 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT03675386 - Reducing Opioid Use for Chronic Pain Patients Following Surgery N/A
Completed NCT02593474 - Medication-Assisted Treatment for Youth With Substance Use Disorders Phase 1
Completed NCT02282306 - Phone Interview to Prevent Recurring Opioid Overdoses N/A
Completed NCT02294253 - Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone Phase 2/Phase 3
Completed NCT01592461 - Starting Treatment With Agonist Replacement Therapies Follow-up Study N/A
Terminated NCT00768482 - A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence Phase 3
Completed NCT01741350 - Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users N/A
Terminated NCT04121546 - Collaborative Care for Opioid Dependence And Pain Pilot Study N/A
Withdrawn NCT03368794 - Naloxone to TReatment Entry in the Emergency Setting N/A
Completed NCT03447743 - Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder Early Phase 1
Completed NCT04464421 - SMART Effectiveness Trial N/A
Recruiting NCT04189523 - Does Early Administration of Ultrasound Guided Regional Anesthesia for Long Bone Fractures Effect Long Term Patient Opioid Usage N/A
Completed NCT03305666 - Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures Phase 4
Recruiting NCT04003948 - Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification Phase 2
Not yet recruiting NCT03813095 - Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction Phase 2
Terminated NCT02935101 - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants Phase 2
Completed NCT01895270 - Improving Buprenorphine Detoxification Outcomes With Isradipine Phase 1/Phase 2
Completed NCT01717963 - Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway Phase 3
Completed NCT02324725 - Biomarkers of Injectable Extended Release Naltrexone Treatment Phase 4
Completed NCT01425060 - Improving Effective Contraceptive Use Among Opioid-maintained Women Phase 1