AlcoholismPhase 4NCT00004554
Sertraline for Alcohol Dependence and Depression
A Phase 4 study testing naltrexone (Revia) and sertraline (Zoloft) in people with Alcoholism and Depression, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will examine depressed alcoholic outpatients to assess whether combining naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking and depression over either medication alone or placebo. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcoholism, Depression
- What is being tested?
- naltrexone (Revia) and sertraline (Zoloft)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Feb 2006
- Phase
- Phase 4
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female outpatients 18 75 years of age.
- Patients must have met DSM-IV criteria for (primary or substance-induced) major depressive episode prior to randomization.
- Patients must have a current DSM-IV diagnosis of alcohol dependence.
- Patients must have a total score of 10 or higher on the Hamilton Depression Scaleat the day of randomization. Also, item 1 on the scale must be > 1.
- Patients must have drank sufficient alcohol in the month prior to coming for treatment so that a practical assessment in reductions in drinking during and after treatment can be performed. The guidelines we will follow for this study as to what we think is sufficient will be that the patient in the month prior to coming to treatment will have drank on 40% or more of the days or drank more than 40 standard drinks (an average of 10 drinks per week).
- Patients must have successfully completed medical detoxification for alcohol (are abstinent for 4 consecutive days) or if medical detoxification is not indicated, have been abstinent for 4 consecutive days since coming to treatment but before initiating the study medication/placebo.
- Females of childbearing potential must have a negative pregnancy test and not contemplating pregnancy within the next 6 months. They must also use a contraceptive method judged by the investigator to be effective.
Who cannot join
- Patients with evidence of opiate use in the past 30 days as assessed by self-report and intake urine drug screens (only one repeat testing permitted). Patients with a history of treatment for opiate dependence will be excluded.
- Patients who, within the past year, met DSM IV criteria for dependence on any psychoactive substance other than alcohol or nicotine. Patients who test positive on the urine drug screen (with the exception of THC) at the initial visit (only one repeat testing permitted).
- Patients who meet DSM-IV criteria for past history or current disorder of schizophrenia or any psychotic disorder, or bipolar disorder.
- Patients with evidence or history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease. (If there is a history of such disease but the condition has been stable for more than one year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.)
- Patients with abnormal liver function tests (AST or ALT) (more than 3.5 times the upper level of the normal value) or patients with any abnormal elevation in bilirubin.
- Patients requiring concomitant therapy with any psychotropic drug (with the exception of benadryl used sparingly if necessary for sleep or oxeazepam for detoxification or nicotine replacement therapy).
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- Patients who have taken fluoxetine (Prozac) during the 6 weeks prior to randomization --due to its long half-life.
- Patients who have taken monoamine oxidase inhibitors (MAOI) during the 2 weeks prior to randomization -- due to the potential toxicity of combining MAOI medications with serotonin-specific ones. (Patients will also be instructed not to take MAOI for 2 weeks after completing the study.)
- Past use of antidepressants or other psychotropic medications (except as specified above) within 7 days of randomization.
- Patients on concomitant therapy with an investigational drug, or patients who have been in an investigational drug study within one month prior to entering this study.
- Patients who are unable to read or print in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Treatment Research Center, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This study will examine depressed alcoholic outpatients to assess whether combining naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking and depression over either medication alone or placebo. A secondary aim is to determine whether certain patient features will predict response to sertraline, naltrexone or the combination of the two drugs. Subjects will be randomized into treatment groups for 14 weeks. The followup phase includes two visits at 6 and 9 months after treatment.
Read the detailed description
The proposed study will examine managing relapse in patients with alcohol dependence and depression using a 14-week double-blind, placebo-controlled, combination of 100 mg/day of naltrexone, 200 mg/day of sertraline, and individual, cognitive behavioral therapy (CBT). For testing the medication, the design will be 2x2, consisting of four groups: naltrexone/sertraline, naltrexone only, sertraline only, placebo. All four groups will receive once weekly sessions of CBT given by therapists experienced in working with patients with substance disorders and trained in the principles of CBT.
- Conditions
- Alcoholism, Depression
- Being tested
- naltrexone (Revia), sertraline (Zoloft), Placebo
- Medical subject headings
- Alcoholism, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naltrexone (Revia)Drug
100mg/day
sertraline (Zoloft)Drug
200mg/day
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Sertraline | Experimental | sertraline Receives: Drug: sertraline (Zoloft) |
| Naltrexone | Experimental | naltrexone Receives: Drug: naltrexone (Revia) |
| Nal/Sert | Experimental | naltrexone/sertraline Receives: Drug: naltrexone (Revia); Drug: sertraline (Zoloft) |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects self-report of alcohol use, measured by the Timeline Followback (TLFB), and depressive symptoms measured by scores on the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HRSD).
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2000 (estimated)
- Study startJan 2000
- Primary completionAug 2005
- Study completionFeb 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.
- More trials run by University of PennsylvaniaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen Pettinati, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004554
- Sponsor's protocol ID
- NIAAAPET09544
- Status last verified
- Sep 2013
- First submitted
- 4 Feb 2000
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pettinati HM, Oslin DW, Kampman KM, Dundon WD, Xie H, Gallis TL, Dackis CA, O'Brien CP. A double-blind, placebo-controlled trial combining sertraline and naltrexone for treating co-occurring depression and alcohol dependence. Am J Psychiatry. 2010 Jun;167(6):668-75. doi: 10.1176/appi.ajp.2009.08060852. Epub 2010 Mar 15.
PubMed 20231324
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sertraline for Alcohol Dependence and Depression
- ClinicalTrials.gov ID
- NCT00004554
- Acronym / sponsor ID
- NIAAAPET09544
- Conditions
- Alcoholism, Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Aug 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 7 Feb 2000 (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 will examine depressed alcoholic outpatients to assess whether combining naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking and depression over either medication alone or placebo. A secondary aim is to determine whether certain patient features will predict response to sertraline, naltrexone or the combination of the two drugs. Subjects will be randomized into treatment groups for 14 weeks. The followup phase includes two visits at 6 and 9 months after treatment.
Detailed description
The proposed study will examine managing relapse in patients with alcohol dependence and depression using a 14-week double-blind, placebo-controlled, combination of 100 mg/day of naltrexone, 200 mg/day of sertraline, and individual, cognitive behavioral therapy (CBT). For testing the medication, the design will be 2x2, consisting of four groups: naltrexone/sertraline, naltrexone only, sertraline only, placebo. All four groups will receive once weekly sessions of CBT given by therapists experienced in working with patients with substance disorders and trained in the principles of CBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sertraline | Experimental | Drug: sertraline (Zoloft)sertraline |
| Naltrexone | Experimental | Drug: naltrexone (Revia)naltrexone |
| Nal/Sert | Experimental | Drug: naltrexone (Revia), Drug: sertraline (Zoloft)naltrexone/sertraline |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female outpatients 18 75 years of age.
- Patients must have met DSM-IV criteria for (primary or substance-induced) major depressive episode prior to randomization.
- Patients must have a current DSM-IV diagnosis of alcohol dependence.
- Patients must have a total score of 10 or higher on the Hamilton Depression Scaleat the day of randomization. Also, item 1 on the scale must be > 1.
- Patients must have drank sufficient alcohol in the month prior to coming for treatment so that a practical assessment in reductions in drinking during and after treatment can be performed. The guidelines we will follow for this study as to what we think is sufficient will be that the patient in the month prior to coming to treatment will have drank on 40% or more of the days or drank more than 40 standard drinks (an average of 10 drinks per week).
Key exclusion criteria (11 listed)
- Patients with evidence of opiate use in the past 30 days as assessed by self-report and intake urine drug screens (only one repeat testing permitted). Patients with a history of treatment for opiate dependence will be excluded.
- Patients who, within the past year, met DSM IV criteria for dependence on any psychoactive substance other than alcohol or nicotine. Patients who test positive on the urine drug screen (with the exception of THC) at the initial visit (only one repeat testing permitted).
- Patients who meet DSM-IV criteria for past history or current disorder of schizophrenia or any psychotic disorder, or bipolar disorder.
- Patients with evidence or history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease. (If there is a history of such disease but the condition has been stable for more than one year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.)
- Patients with abnormal liver function tests (AST or ALT) (more than 3.5 times the upper level of the normal value) or patients with any abnormal elevation in bilirubin.
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 |
|---|---|---|
| naltrexone (Revia)100mg/day | Drug | Nal/Sert, Naltrexone |
| sertraline (Zoloft)200mg/day | Drug | Nal/Sert, Sertraline |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Subjects self-report of alcohol use, measured by the Timeline Followback (TLFB), and depressive symptoms measured by scores on the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HRSD).
Time frame: 14 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 6 Oct 2015.
- Results publication: PubMed 20231324Pettinati HM, Oslin DW, Kampman KM, Dundon WD, Xie H, Gallis TL, Dackis CA, O'Brien CP. A double-blind, placebo-controlled trial combining sertraline and naltrexone for treating co-occurring depression and alcohol dependence. Am J Psychiatry. 2010 Jun;167(6):668-75. doi: 10.1176/appi.ajp.2009.08060852. Epub 2010 Mar 15.
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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.
Helen Pettinati, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing naltrexone (Revia) and sertraline (Zoloft) in people with Alcoholism and Depression, run by University of Pennsylvania 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 7 inclusion and 11 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 6 Oct 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Subjects self-report of alcohol use, measured by the Timeline Followback (TLFB), and depressive symptoms measured by scores on the Beck Depression Inventory (BDI) and Hamilton Rating Scale for Depression (HRSD). (time frame: 14 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 NCT00004554, 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 6 Oct 2015.