BenzodiazepinesPhase 3NCT00261183
The Contribution of Melatonin Vs. Placebo in Benzodiazepine Withdrawal in Methadone Maintenance Treatment Patients
A Phase 3 study testing Melatonin in people with Benzodiazepines, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
We hypothesized that patient will success in benzodiazepine withdrawal if they get melatonin to solve sleep-problems which commonly occur during benzodiazepine withdrawal. Former heroin addicts, currently in Methadone maintenance treatment, who are also abusing benzodiazepine, started self benzodiazepine withdrawal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benzodiazepines
- What is being tested?
- Melatonin
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2004to Dec 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Former opiates addicts, currently in methadone maintenance treatment, and abusing benzodiazepines who intend to withdrawal
- adults (>=18y)
Who cannot join
- non abusing benzodiazepine
- Refuse making benzodiazepines withdrawal
- non methadone maintenance treatment patients
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shaul Schreiber
Tel Aviv
Shaul Schreiber, MD, 97236973226, shaulsch@tasmc.health.gov.il
Shaul Schreiber, MD
About this study
We hypothesized that patient will success in benzodiazepine withdrawal if they get melatonin to solve sleep-problems which commonly occur during benzodiazepine withdrawal. Former heroin addicts, currently in Methadone maintenance treatment, who are also abusing benzodiazepine, started self benzodiazepine withdrawal, and got for 6 weeks melatonin (5mg/day, taken every night) or placebo and after 1 week, additional 6 weeks with placebo or melatonin (double blind for what got first).Success The benzodiazepine withdrawal success was evaluated by urine for benzodiazepines, and sleep quality was evaluated using PSQI questionnaire (baseline,and after weeks 6, 7, 13)
Read the detailed description
A total of 100 patients will participate. Follow-up of benzodiazepines in urine after study and 6 months later will be evaluated, as well as sleep quality (using PSQI)
- Conditions
- Benzodiazepines
- Being tested
- Melatonin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Stop benzodiazepine abuse(Urine)
Secondary outcomes (1)
sleep quality (self report- PSQI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startDec 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BenzodiazepinesStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Shaul Schreiber, MD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261183
- Sponsor's protocol ID
- TASMC-05-SS-03186-CTIL
- Status last verified
- Nov 2005
- First submitted
- 1 Dec 2005
- Last updated
- 2 Dec 2005
- Results posted
- No
Publications
Possemato K, Johnson EM, Emery JB, Wade M, Acosta MC, Marsch LA, Rosenblum A, Maisto SA. A pilot study comparing peer supported web-based CBT to self-managed web CBT for primary care veterans with PTSD and hazardous alcohol use. Psychiatr Rehabil J. 2019 Sep;42(3):305-313. doi: 10.1037/prj0000334. Epub 2018 Nov 29.
PubMed 30489140Peles E, Hetzroni T, Bar-Hamburger R, Adelson M, Schreiber S. Melatonin for perceived sleep disturbances associated with benzodiazepine withdrawal among patients in methadone maintenance treatment: a double-blind randomized clinical trial. Addiction. 2007 Dec;102(12):1947-53. doi: 10.1111/j.1360-0443.2007.02007.x. Epub 2007 Oct 4.
PubMed 17916225
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Melatonin Vs. Placebo in Benzodiazepine Withdrawal in Methadone Maintenance Treatment Patients
- ClinicalTrials.gov ID
- NCT00261183
- Acronym / sponsor ID
- TASMC-05-SS-03186-CTIL
- Conditions
- Benzodiazepines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Dec 2004
- Study completion
- Dec 2006
- First posted
- 2 Dec 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.
We hypothesized that patient will success in benzodiazepine withdrawal if they get melatonin to solve sleep-problems which commonly occur during benzodiazepine withdrawal. Former heroin addicts, currently in Methadone maintenance treatment, who are also abusing benzodiazepine, started self benzodiazepine withdrawal, and got for 6 weeks melatonin (5mg/day, taken every night) or placebo and after 1 week, additional 6 weeks with placebo or melatonin (double blind for what got first).Success The benzodiazepine withdrawal success was evaluated by urine for benzodiazepines, and sleep quality was evaluated using PSQI questionnaire (baseline,and after weeks 6, 7, 13)
Detailed description
A total of 100 patients will participate. Follow-up of benzodiazepines in urine after study and 6 months later will be evaluated, as well as sleep quality (using PSQI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Former opiates addicts, currently in methadone maintenance treatment, and abusing benzodiazepines who intend to withdrawal
- adults (>=18y)
Key exclusion criteria (3 listed)
- non abusing benzodiazepine
- Refuse making benzodiazepines withdrawal
- non methadone maintenance treatment patients
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 |
|---|---|---|
| Melatonin | Drug | – |
Primary outcome
Stop benzodiazepine abuse(Urine)
1 secondary outcome
sleep quality (self report- PSQI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2005.
- Derived from this study: PubMed 30489140Possemato K, Johnson EM, Emery JB, Wade M, Acosta MC, Marsch LA, Rosenblum A, Maisto SA. A pilot study comparing peer supported web-based CBT to self-managed web CBT for primary care veterans with PTSD and hazardous alcohol use. Psychiatr Rehabil J. 2019 Sep;42(3):305-313. doi: 10.1037/prj0000334. Epub 2018 Nov 29.
- Derived from this study: PubMed 17916225Peles E, Hetzroni T, Bar-Hamburger R, Adelson M, Schreiber S. Melatonin for perceived sleep disturbances associated with benzodiazepine withdrawal among patients in methadone maintenance treatment: a double-blind randomized clinical trial. Addiction. 2007 Dec;102(12):1947-53. doi: 10.1111/j.1360-0443.2007.02007.x. Epub 2007 Oct 4.
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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.
Shaul Schreiber, MD principal investigator
Tel Aviv Medical Center
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 Melatonin in people with Benzodiazepines, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 2 Dec 2005. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Einat Peles, Ph.D. (97236973226, einatp@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stop benzodiazepine abuse(Urine). 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 NCT00261183, which also lists 2 linked publications.
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 2 Dec 2005.