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Opiate DependencePhase 2NCT00684788

Employment-Based Depot Naltrexone Clinical Trial

A Phase 2 study testing employment-based reinforcement in people with Opiate Dependence, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Opiate Dependence
What is being tested?
employment-based reinforcement
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
May 2006to 3 May 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Individuals were eligible if they:

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Center for Learning and Health

    Baltimore, Maryland, 21224

Other trials in United States

About this study

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

Read the detailed description

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.

Being tested
employment-based reinforcement
Keywords
opiate dependence, naltrexone, reinforcement, behavior therapy, cocaine dependence, risk reduction behavior
Medical subject headings
Opioid-Related Disorders, Cocaine-Related Disorders, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • employment-based reinforcementCombination product

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

Study groups in NCT00684788
Study groupRoleWhat they receive
No InterventionNo interventionParticipants were offered depot naltrexone injections and were not required to take scheduled injections to work.
Employment-based reinforcementExperimentalParticipants were offered depot naltrexone injections and were required to take scheduled injections to work.
Receives: Combination Product: employment-based reinforcement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Depot Naltrexone Doses Received

    The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.

    Measured: 18 Weeks

Secondary outcomes (6)

  1. The Time to the First Missed Dose of Depot Naltrexone

    The number of weeks until the first missed dose of depot naltrexone

    Measured: 18 weeks

  2. Percentage of 30-day Assessments Urine Samples Negative for Opiates

    (The number of urine samples that were negative for opiates/total number of urine samples)x 100

    Measured: 4 months

  3. Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates

    Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100

    Measured: 18 weeks

  4. Percentage of 30-day Assessments Urine Samples Negative for Cocaine

    (The number of urine samples that were negative for cocaine/total number of urine samples)x 100

    Measured: 4 months

  5. Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine

    Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100

    Measured: 18 weeks

  6. HIV Risk Behaviors

    Went to a crack house

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2008 (estimated)
  2. Study startMay 2006
  3. Primary completionMay 2009
  4. Study completion3 May 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00684788
Sponsor's protocol ID
NA_00000928-1
Other IDs
R01DA019497
Status last verified
Nov 2017
First submitted
23 May 2008
Last updated
26 Dec 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21320227

  • 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.

    PubMed 21782353

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing employment-based reinforcement in people with Opiate Dependence, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Depot Naltrexone Doses Received (time frame: 18 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00684788, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.

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