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Employment-Based Depot Naltrexone Clinical Trial

NCT ID: NCT00684788

Last Updated: 2017-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-05-03

Brief Summary

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The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.

Detailed Description

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A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone adherence in opiate-dependent adults. An extended-release depot formulation of naltrexone will be used. Participants will be offered an inpatient opioid detoxification and naltrexone induction. Participants who complete the oral naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Patients in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone once per month. "Work Plus Naltrexone Prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.

Conditions

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Opiate Dependence

Keywords

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opiate dependence naltrexone reinforcement behavior therapy cocaine dependence risk reduction behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Intervention

Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.

Group Type NO_INTERVENTION

No interventions assigned to this group

Employment-based reinforcement

Participants were offered depot naltrexone injections and were required to take scheduled injections to work.

Group Type EXPERIMENTAL

employment-based reinforcement

Intervention Type COMBINATION_PRODUCT

Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.

Interventions

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employment-based reinforcement

Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* met the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) criteria for opioid dependence,
* reported using heroin on at least 21 of the last 30 days while in community,
* were unemployed,
* were aged 18-65 years,
* were medically approved for naltrexone
* lived in or near Baltimore, MD.

Individuals were excluded if they

* had current DSM-IV major Axis I disorders,
* had current suicidal or homicidal ideation,
* expressed interest in methadone treatment,
* were required to use opioids for medical purposes,
* earned more than $200 in taxable income over the previous 30 days,
* had physical limitations that would prevent them from using a keyboard,
* were pregnant or breastfeeding,
* had serum aminotransferase levels more than three times over normal.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth Silverman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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The Center for Learning and Health

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Everly JJ, DeFulio A, Koffarnus MN, Leoutsakos JM, Donlin WD, Aklin WM, Umbricht A, Fingerhood M, Bigelow GE, Silverman K. Employment-based reinforcement of adherence to depot naltrexone in unemployed opioid-dependent adults: a randomized controlled trial. Addiction. 2011 Jul;106(7):1309-18. doi: 10.1111/j.1360-0443.2011.03400.x. Epub 2011 May 3.

Reference Type RESULT
PMID: 21320227 (View on PubMed)

DeFulio A, Everly JJ, Leoutsakos JM, Umbricht A, Fingerhood M, Bigelow GE, Silverman K. Employment-based reinforcement of adherence to an FDA approved extended release formulation of naltrexone in opioid-dependent adults: a randomized controlled trial. Drug Alcohol Depend. 2012 Jan 1;120(1-3):48-54. doi: 10.1016/j.drugalcdep.2011.06.023. Epub 2011 Jul 22.

Reference Type DERIVED
PMID: 21782353 (View on PubMed)

Other Identifiers

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R01DA019497

Identifier Type: NIH

Identifier Source: secondary_id

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NA_00000928-1

Identifier Type: -

Identifier Source: org_study_id