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Opiate DependencePhase 2NCT00684775

Employment-Based Depot Naltrexone Clinical Trial II

A Phase 2 study testing Work Plus Naltrexone Contingency 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?
Work Plus Naltrexone Contingency
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
May 2008to 30 Apr 2010
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 (DSM)-IV criteria for opioid dependence,
  • reported using heroin at least 21 of the last 30 days while living in the community,
  • were unemployed,
  • were 18-65 years old,
  • were medically approved for naltrexone,
  • lived in or near Baltimore, MD.

Individuals were excluded if they:

  • were pregnant or breastfeeding,
  • had serum aminotransferase levels over three times normal,
  • had current hallucinations, delusions, or thought disorders, current suicidal or -homicidal ideation,
  • expressed interest in methadone treatment,
  • were required to use opioids for medical purposes,
  • earned over $200 in taxable income over the previous 30 days,
  • had physical limitations that would prevent them from using a keyboard, or were incarcerated or under constant monitoring by the criminal justice system.

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 to evaluate the effectiveness of employment-based reinforcement in promoting depot naltrexone adherence in opiate-dependent adults. Vivitrol, an extended-release depot formulation of naltrexone approved by the FDA for the treatment of alcohol dependence, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) 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. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections 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
Work Plus Naltrexone Contingency
Medical subject headings
Opioid-Related Disorders

What participants receive

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

  • Work Plus Naltrexone ContingencyCombination product

    Also called contingency management

    Vivitrol, an extended-release depot formulation of naltrexone, was used. Participants were offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) were 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. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.

Study groups in NCT00684775
Study groupRoleWhat they receive
Work Plus Naltrexone PrescriptionNo interventionParticipants could work and earn vouchers but did not to take Vivitrol Injections to work and earn vouchers.
Work Plus Naltrexone ContingencyExperimentalParticipants could work and earn vouchers and had to take Vivitrol Injections to work and earn vouchers: employment-based reinforcement.
Receives: Combination Product: Work Plus Naltrexone Contingency

What is being measured

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

  1. Naltrexone Injections Received

    The percentage of depot naltrexone doses that participants received

    Measured: 24 weeks

  2. Time to the First Missed Dose

    The time to the first missed dose of depot naltrexone

    Measured: 24 weeks

Secondary outcomes (5)

  1. Percentage of 30-day Urine Samples Negative for Opiates

    Percentage of urine samples collected at the 30-day assessments that are negative for opiates

    Measured: Collected every 30 days for 150 days

  2. Percentage of M-W-F Samples Negative for Cocaine

    Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine

    Measured: Collected every Monday, Wednesday and Friday for 24 weeks

  3. Average Percentage of 30-day Urine Samples Negative for Cocaine

    The percentage of urine samples collected at 30-day assessments that are negative for cocaine.

    Measured: Collected every 30 days for 150 days

  4. HIV Risk Behaviors

    behaviors that place participants at risk for acquiring or transmitting HIV infection

    Measured: 24 weeks

  5. Percentage of M,W,F Urine Samples Negative for Opiates

    Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for opiates

    Measured: Collected every Monday, Wednesday and Friday for 24 weeks

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 2008
  3. Primary completion30 Apr 2010
  4. Study completion30 Apr 2010

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00684775
Sponsor's protocol ID
NIDA-19497-2
Other IDs
R01DA019497-02, NA_00000928
Status last verified
Dec 2017
First submitted
23 May 2008
Last updated
23 Jan 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 Work Plus Naltrexone Contingency 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 23 Jan 2018. 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?

Naltrexone Injections Received (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 NCT00684775, which also lists 1 linked publication.

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 23 Jan 2018.

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