Opioid-Related DisordersNCT00237406
Interactive Voice Response (IVR) for Methadone Patients
An observational study of Opioid-Related Disorders, run by Butler Hospital at 1 site in United States.
Trial summary
This study is designed to test whether a telephone call-in program is a feasible way to collect mood and drug-related information in individuals enrolled in a methadone maintenance program. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- interactive voice response
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Oct 2006
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who recently enrolled in methadone maintenance for opioid addiction.
Who may be able to join
- Recent enrollment in a methadone maintenance program
Who cannot join
- Enrollment in a methadone maintenance program within the prior 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Interactive Voice Response for Methadone Patients
This study is designed to test whether a telephone call-in program is a feasible way to collect mood and drug-related information in individuals enrolled in a methadone maintenance program.
Read the detailed description
Participants will complete a baseline interview and a follow-up interview at 5-weeks post-baseline. Two-thirds of the participants will be randomized into the telephone call-in group, and will be asked to complete daily, 10-minute, telephone interviews. To complete these interviews, participants will call into a toll-free telephone interview system with a unique and private Study ID number, and answers questions by using the telephone key pad. Questions during both the face-to-face interviews and the telephone interviews will assess mood, sleep, treatment utilization and drug-related experiences. Participants will be compensated for their time.
Comparison(s): Participants randomized into the telephone component of the study as compared to participants in the interview-only component of the study.
- Conditions
- Opioid-Related Disorders
- Being tested
- interactive voice response
- Keywords
- IVR, methadone, methadone maintenance
- 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.
interactive voice responseProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJan 2006
- Study completionOct 2006
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Michael D Stein, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237406
- Sponsor's protocol ID
- 4065-05
- Status last verified
- Mar 2010
- First submitted
- 11 Oct 2005
- Last updated
- 25 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Voice Response for Methadone Patients
- ClinicalTrials.gov ID
- NCT00237406
- Acronym / sponsor ID
- 4065-05
- Conditions
- Opioid-Related Disorders
- Keywords
- IVR, methadone, methadone maintenance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Oct 2006 (actual)
- First posted
- 12 Oct 2005 (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.
This study is designed to test whether a telephone call-in program is a feasible way to collect mood and drug-related information in individuals enrolled in a methadone maintenance program.
Detailed description
Participants will complete a baseline interview and a follow-up interview at 5-weeks post-baseline. Two-thirds of the participants will be randomized into the telephone call-in group, and will be asked to complete daily, 10-minute, telephone interviews. To complete these interviews, participants will call into a toll-free telephone interview system with a unique and private Study ID number, and answers questions by using the telephone key pad. Questions during both the face-to-face interviews and the telephone interviews will assess mood, sleep, treatment utilization and drug-related experiences. Participants will be compensated for their time.
Comparison(s): Participants randomized into the telephone component of the study as compared to participants in the interview-only component of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who recently enrolled in methadone maintenance for opioid addiction.
Key inclusion criteria (1 listed)
- Recent enrollment in a methadone maintenance program
Key exclusion criteria (1 listed)
- Enrollment in a methadone maintenance program within the prior 3 months
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 |
|---|---|---|
| interactive voice response | Procedure or surgery | – |
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 25 Mar 2010.
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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.
Michael D Stein, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-Related Disorders, run by Butler Hospital 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?
The sponsor lists 1 inclusion and 1 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 25 Mar 2010. 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.
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 25 Mar 2010.