AlcoholismPhase 2SIESTANCT00027053
Trazodone for Sleep Disturbance in Early Alcohol Recovery
A Phase 2 study testing Trazodone in people with Alcoholism, run by Rhode Island Hospital at 1 site in United States.
Trial summary
This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpatient detoxification program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Trazodone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Jun 2006
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed an alcohol detoxification program.
- Meets criteria for alcohol dependence.
- Meets criteria for sleep disturbance.
- If female of childbearing potential must be using adequate contraception.
- Has a location to which they will return after the initial research interview and a person they regularly contact.
- Speaks English sufficiently to understand instructions and assessment.
Who cannot join
- Meets criteria for substance dependence for sedative/hypnotic drugs, stimulants, cocaine or opiates, or of organic brain disorder, bipolar disorder, schizophrenia, schizoaffective, schizophreniform, or paranoid disorder, or major depression.
- Current suicidality.
- Use of psychotropic, antidepressant, anxiolytic or antidipsogenic medication.
- Inability or refusal to terminate the use of proerectile agents, herbal medications or sleep medication for the study period.
- The presence of contraindications to the study medications, including pregnancy/lactation, ischemic heart disease, cardiac arrhythmias, priapism or hypotension.
- Presence of comorbid medical conditions associated with sleep disturbance including obstructive sleep apnea, poorly controlled diabetes mellitus or emphysema.
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- Evidence of neuropsychological dysfunction.
- Probation/parole requirements that might interfere with participation in study.
- Inability to identify at least one contact person.
- Living on the street after detoxification (homeless persons living in a shelter, halfway house or other residence will not be excluded).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Trazodone for Sleep Disturbance - Early Alcohol Recovery
This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpatient detoxification program. Subjects will undergo a baseline assessment and random assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.)
- Conditions
- Alcoholism
- Being tested
- Trazodone, Placebo
- Keywords
- alcoholism, alcohol dependence, trazadone, sleep
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrazodoneDrug
50 to 150 mg qhs
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Trazodone | Experimental | Not described Receives: Drug: Trazodone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent days abstinent from alcohol (PDA)
Measured: 12 and 24 weeks
Secondary outcomes (2)
sleep quality
Measured: 12 and 24 weeks
Drinks per drinking day
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2001 (estimated)
- Study startJun 2002
- Primary completionJan 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies 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
- Double blind
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Peter D. Friedmann, MD, MPH, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027053
- Sponsor's protocol ID
- NIAAAFRI13243
- Other IDs
- R01AA013243, NIH grant R01 AA013243
- Acronym
- SIESTA
- Status last verified
- Mar 2006
- First submitted
- 19 Nov 2001
- Last updated
- 13 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Friedmann PD, Rose JS, Swift R, Stout RL, Millman RP, Stein MD. Trazodone for sleep disturbance after alcohol detoxification: a double-blind, placebo-controlled trial. Alcohol Clin Exp Res. 2008 Sep;32(9):1652-60. doi: 10.1111/j.1530-0277.2008.00742.x. Epub 2008 Jul 8.
PubMed 18616688
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trazodone for Sleep Disturbance - Early Alcohol Recovery
- ClinicalTrials.gov ID
- NCT00027053
- Acronym / sponsor ID
- SIESTA / NIAAAFRI13243
- Conditions
- Alcoholism
- Keywords
- alcoholism, alcohol dependence, trazadone, sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jun 2002
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 20 Nov 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.
This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpatient detoxification program. Subjects will undergo a baseline assessment and random assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trazodone | Experimental | Drug: Trazodone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Completed an alcohol detoxification program.
- Meets criteria for alcohol dependence.
- Meets criteria for sleep disturbance.
- If female of childbearing potential must be using adequate contraception.
- Has a location to which they will return after the initial research interview and a person they regularly contact.
Key exclusion criteria (10 listed)
- Meets criteria for substance dependence for sedative/hypnotic drugs, stimulants, cocaine or opiates, or of organic brain disorder, bipolar disorder, schizophrenia, schizoaffective, schizophreniform, or paranoid disorder, or major depression.
- Current suicidality.
- Use of psychotropic, antidepressant, anxiolytic or antidipsogenic medication.
- Inability or refusal to terminate the use of proerectile agents, herbal medications or sleep medication for the study period.
- The presence of contraindications to the study medications, including pregnancy/lactation, ischemic heart disease, cardiac arrhythmias, priapism or hypotension.
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 |
|---|---|---|
| Trazodone50 to 150 mg qhs | Drug | Trazodone |
| Placebo | Drug | Placebo |
Primary outcome
Percent days abstinent from alcohol (PDA)
Time frame: 12 and 24 weeks
2 secondary outcomes
sleep quality
Time frame: 12 and 24 weeks
Drinks per drinking day
Time frame: 12 and 24 weeks
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 13 May 2010.
- Results publication: PubMed 18616688Friedmann PD, Rose JS, Swift R, Stout RL, Millman RP, Stein MD. Trazodone for sleep disturbance after alcohol detoxification: a double-blind, placebo-controlled trial. Alcohol Clin Exp Res. 2008 Sep;32(9):1652-60. doi: 10.1111/j.1530-0277.2008.00742.x. Epub 2008 Jul 8.
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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.
Peter D. Friedmann, MD, MPH 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?
A Phase 2 study testing Trazodone in people with Alcoholism, run by Rhode Island 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 6 inclusion and 10 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 13 May 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. 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 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.
What does the primary outcome measure?
Percent days abstinent from alcohol (PDA) (time frame: 12 and 24 weeks). 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 NCT00027053, 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 13 May 2010.