Substance-Related DisordersPhase 3NCT00067171
Telephone Enhancement Procedure for Continuing Care - 1
A Phase 3 study testing Behavior Therapy in people with Substance-Related Disorders, run by Duke University at 4 sites in United States.
Trial summary
The purpose of this study is to test a feasibility study of a telephone enhancement procedure (TELE) to improve participation in continuing care activities. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 339 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2003to Jan 2004
- Phase
- Phase 3
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residential substance abuse treatment patients who reside within the pre-specified catchment area who complete continuing care plans prior to discharge.
- Voluntary admit to residential treatment center; substance abuse or dependence; reside in targeted counties; and may be reached by telephone.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Julian F. Keith
Black Mountain, North Carolina, 28711
Morris Village Alcohol & Drug Treatment Center
Columbia, South Carolina, 29203
Walter B. Jones, ADATC
Greenville, North Carolina, 27834
James Gilmore Jr. Treatment Center
Kalamazoo, Michigan, 49408
About this study
Official title: Telephone Enhancement Procedure (TELE) for Continuing Care
The purpose of this study is to test a feasibility study of a telephone enhancement procedure (TELE) to improve participation in continuing care activities.
- Conditions
- Substance-Related Disorders
- Being tested
- Behavior Therapy
- Keywords
- behavioral intervention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment compliance, drug and alcohol astinence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2003 (estimated)
- Study startJan 2003
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 3
- Allocation
- Randomised
- Enrolment
- 339 participants
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Investigators
- Robert Hubbard, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067171
- Sponsor's protocol ID
- NIDA-CTN-0011-1
- Status last verified
- Oct 2016
- First submitted
- 12 Aug 2003
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Enhancement Procedure (TELE) for Continuing Care
- ClinicalTrials.gov ID
- NCT00067171
- Acronym / sponsor ID
- NIDA-CTN-0011-1
- Conditions
- Substance-Related Disorders
- Keywords
- behavioral intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 13 Aug 2003 (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 study is to test a feasibility study of a telephone enhancement procedure (TELE) to improve participation in continuing care activities.
Study design
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Residential substance abuse treatment patients who reside within the pre-specified catchment area who complete continuing care plans prior to discharge.
- Voluntary admit to residential treatment center; substance abuse or dependence; reside in targeted counties; and may be reached by telephone.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Behavior Therapy | Behavioural | – |
Primary outcome
Treatment compliance, drug and alcohol astinence
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 12 Jan 2017.
- Data ElementsLink provided by the sponsor.
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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.
Robert Hubbard, Ph.D. principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavior Therapy in people with Substance-Related Disorders, run by Duke University at 4 sites 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?
The sponsor lists 2 inclusion and 0 exclusion criteria. 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Treatment compliance, drug and alcohol astinence. It is what the study was designed to measure, not a finding.
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 12 Jan 2017.