Opioid-Related DisordersPhase 2NCT00018226
Effect Of Case Management Following Discharge From Methadone Treatment
A Phase 2 study testing Case Management in people with Opioid-Related Disorders, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this project is to assess whether enhanced outreach counseling (EOC) is an effective outreach strategy for discharged methadone maintenance patients compared to a standard referral procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Case Management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 1998to Mar 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patients who have been discharged from methadone maintenance treatment at the PVAMC who consented (as active patients) to be contacted for follow-up upon discharge.
Trial locations and contacts
1 site in 1 country.
United States1 site
Drug Dependent Treatment Unit
Philadelphia, Pennsylvania, 19104
About this study
Official title: Enhanced Outreach Counseling Following Methadone Treatment Discharge
The purpose of this project is to assess whether enhanced outreach counseling (EOC) is an effective outreach strategy for discharged methadone maintenance patients compared to a standard referral procedure. EOC is a brief (30 minute) face-to-face intervention, followed by six weeks of ongoing telephone counseling/case management designed to help eligible out-of-treatment methadone patients re-enter treatment. Several studies have shown those patients who voluntarily re-enter treatment improve significantly following re-enrollment.
- Conditions
- Opioid-Related Disorders
- Being tested
- Case Management
- 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.
Case ManagementBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2001 (estimated)
- Study startApr 1998
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018226
- Sponsor's protocol ID
- ADRD-022-97S
- Status last verified
- Dec 2004
- First submitted
- 3 Jul 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Outreach Counseling Following Methadone Treatment Discharge
- ClinicalTrials.gov ID
- NCT00018226
- Acronym / sponsor ID
- ADRD-022-97S
- Conditions
- Opioid-Related Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 1998
- Study completion
- Mar 2001
- First posted
- 5 Jul 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to assess whether enhanced outreach counseling (EOC) is an effective outreach strategy for discharged methadone maintenance patients compared to a standard referral procedure. EOC is a brief (30 minute) face-to-face intervention, followed by six weeks of ongoing telephone counseling/case management designed to help eligible out-of-treatment methadone patients re-enter treatment. Several studies have shown those patients who voluntarily re-enter treatment improve significantly following re-enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case Management | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Case Management in people with Opioid-Related Disorders, run by US Department of Veterans Affairs 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 21 Jan 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 21 Jan 2009.