Poor Quality SleepPhase 3NCT00253890
Insomnia and Drug Relapse Risk
A Phase 3 study testing Trazodone in people with Poor Quality Sleep and Opiate Addiction, run by Butler Hospital at 1 site in United States.
Trial summary
The purposes of this study are: 1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and 2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Poor Quality Sleep, Opiate Addiction
- What is being tested?
- Trazodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to May 2010
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent methadone maintenance enrollment
- Sleep complaints as measured by the Pittsburgh Sleep Quality Index (PSQI)
- No medical contraindications to trazodone
Who cannot join
- Methadone maintenance enrollment not recent
- No sleep complaints as measured by the PSQI
- Medical contraindications to trazodone
Trial locations and contacts
1 site in 1 country.
About this study
The purposes of this study are:
- to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and
- to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.
Read the detailed description
Individuals new to methadone maintenance will be asked to participate in this 6-month, double-blind, randomized control trial. All participants will complete a baseline interview, a medical screening and follow-up interviews at 1, 3 and 6-months post-baseline. These interviews take approximately 60 minutes, and survey various areas of the participants' experiences, including basic demographic information, mood, sleep and substance use areas. All participants will also be asked to complete a 2-night sleep monitoring at the time of the baseline interview and again at the 1-month follow-up interview. Participants will also receive study medication; half of the participants will receive a placebo medication, and the other half will receive Trazodone, a widely-prescribed, well-tolerated, low side-effect medication. Neither the participant nor the study staff will know which medication the participant is taking while the participant is actively enrolled in the study. This information can be available to the participant at the end of his/her study participation.
- Conditions
- Poor Quality Sleep, Opiate Addiction
- Being tested
- Trazodone, Placebo
- Keywords
- sleep quality, methadone, substance use
- Medical subject headings
- Opioid-Related Disorders, Sleep Initiation and Maintenance Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrazodoneDrug
Also called Desyrel, Oleptro, Beneficat, Deprax
50 mg 1-3 capsules at bedtime for 3 months
PlaceboDrug
Also called Sugar pill
1-3 at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Trazodone | Active comparator | 50-150mg (50mg capsules) at bedtime for 90 days Receives: Drug: Trazodone |
| Placebo | Placebo comparator | 1-3 capsules at bedtime for 90 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality, as Measured by Total Sleep Time
Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.
Measured: Baseline to 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Poor Quality SleepStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Michael Stein, MD, Butler Hospital
- Investigators
- Michael D Stein, MD, Principal investigator, Rhode Island HospitalRogers Griffith, MD, Study director, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253890
- Sponsor's protocol ID
- R01DA020479
- Other IDs
- R01DA020479-01
- Status last verified
- Oct 2013
- First submitted
- 10 Nov 2005
- Last updated
- 11 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kurth ME, Sharkey KM, Millman RP, Corso RP, Stein MD. Insomnia among methadone-maintained individuals: the feasibility of collecting home polysomnographic recordings. J Addict Dis. 2009 Jul;28(3):219-25. doi: 10.1080/10550880903014155.
PubMed 20155590
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insomnia and Drug Relapse Risk
- ClinicalTrials.gov ID
- NCT00253890
- Acronym / sponsor ID
- R01DA020479
- Conditions
- Poor Quality Sleep, Opiate Addiction
- Keywords
- sleep quality, methadone, substance use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2005
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Posted 11 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are:
- to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and
- to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.
Detailed description
Individuals new to methadone maintenance will be asked to participate in this 6-month, double-blind, randomized control trial. All participants will complete a baseline interview, a medical screening and follow-up interviews at 1, 3 and 6-months post-baseline. These interviews take approximately 60 minutes, and survey various areas of the participants' experiences, including basic demographic information, mood, sleep and substance use areas. All participants will also be asked to complete a 2-night sleep monitoring at the time of the baseline interview and again at the 1-month follow-up interview. Participants will also receive study medication; half of the participants will receive a placebo medication, and the other half will receive Trazodone, a widely-prescribed, well-tolerated, low side-effect medication. Neither the participant nor the study staff will know which medication the participant is taking while the participant is actively enrolled in the study. This information can be available to the participant at the end of his/her study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trazodone | Active comparator | Drug: Trazodone50-150mg (50mg capsules) at bedtime for 90 days |
| Placebo | Placebo comparator | Drug: Placebo1-3 capsules at bedtime for 90 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recent methadone maintenance enrollment
- Sleep complaints as measured by the Pittsburgh Sleep Quality Index (PSQI)
- No medical contraindications to trazodone
Key exclusion criteria (3 listed)
- Methadone maintenance enrollment not recent
- No sleep complaints as measured by the PSQI
- Medical contraindications to trazodone
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 |
|---|---|---|
| TrazodoneAlso: Desyrel, Oleptro, Beneficat, Deprax50 mg 1-3 capsules at bedtime for 3 months | Drug | Trazodone |
| PlaceboAlso: Sugar pill1-3 at bedtime | Drug | Placebo |
Primary outcome
Sleep Quality, as Measured by Total Sleep Time
Time frame: Baseline to 1-month
Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20155590Kurth ME, Sharkey KM, Millman RP, Corso RP, Stein MD. Insomnia among methadone-maintained individuals: the feasibility of collecting home polysomnographic recordings. J Addict Dis. 2009 Jul;28(3):219-25. doi: 10.1080/10550880903014155.
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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
Rogers Griffith, MD study director
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trazodone in people with Poor Quality Sleep and Opiate Addiction, 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 3 inclusion and 3 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 11 Dec 2013. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2013). 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?
Sleep Quality, as Measured by Total Sleep Time (time frame: Baseline to 1-month). 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 NCT00253890, 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 11 Dec 2013.