Opiate DependencePhase 3NCT00475878
SSRI and Buprenorphine
A Phase 3 study testing escitalopram in people with Opiate Dependence and Depression, run by Butler Hospital at 1 site in United States.
Trial summary
This study is designed to test whether treatment of depressive symptoms using escitalopram improves adherence to Buprenorphine and reduces symptoms of depression for individuals receiving Buprenorphine through their medical provider. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Opiate Dependence, Depression
- What is being tested?
- escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Sep 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- opiate dependence
- Ham-D > 14
Who cannot join
- no psychiatric contraindications to using escitalopram
- no medical contraindications to using escitalopram
- methadone dose < 30
- no current SSRI use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antidepressants During Office-Based Buprenorphine
This study is designed to test whether treatment of depressive symptoms using escitalopram improves adherence to Buprenorphine and reduces symptoms of depression for individuals receiving Buprenorphine through their medical provider.
Read the detailed description
Participants interested in receiving Buprenorphine will be offered the opportunity to enroll in this study. Enrolled study participants will complete interviews at baseline and again every two weeks for a total of 8 interviews over 3 months. In this double-blind randomized controlled trial, participants will either receive a placebo or escitalopram (10mg). All participants will also be followed by their Buprenorphine clinic medical provider. Questions during the face-to-face interviews will assess mood, drug craving, pain, sleep, medication adherence and drug-related experiences. Comparison(s): Participants randomized into the medication component of the study as compared to participants randomized into the placebo component of the study.
- Conditions
- Opiate Dependence, Depression
- Being tested
- escitalopram, placebo
- Keywords
- opiate use, depression, buprenorphine, escitalopram
- Medical subject headings
- Opioid-Related Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
10mg escitalopram/day for 3 months
placeboDrug
placebo capsule/day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| escitalopram | Active comparator | Not described Receives: Drug: escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Dropped Out of Buprenorphine Treatment
Drop-out is defined as 7 or more days of missed Buprenorphine doses
Measured: 3 months
Secondary outcomes (1)
Depressive Symptoms
Depressive symptoms, as measured by self-report during study interviews, using the Beck Depression Inventory II. Scores ranged from 0-63; higher scores indicate more depressive symptoms.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startDec 2006
- Primary completionSep 2009
- Study completionSep 2009
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 (6)Papers the sponsor has linked to this study.
- Other trials for Opiate DependenceStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Stein, MD, Butler Hospital
- Investigators
- Michael D Stein, M.D., Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475878
- Sponsor's protocol ID
- DA022207
- Other IDs
- 0807-002
- Status last verified
- Mar 2012
- First submitted
- 18 May 2007
- Last updated
- 3 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tsui JI, Anderson BJ, Strong DR, Stein MD. Craving predicts opioid use in opioid-dependent patients initiating buprenorphine treatment: a longitudinal study. Am J Drug Alcohol Abuse. 2014 Mar;40(2):163-9. doi: 10.3109/00952990.2013.848875. Epub 2014 Feb 12.
PubMed 24521036Cioe PA, Anderson BJ, Stein MD. Change in symptoms of erectile dysfunction in depressed men initiating buprenorphine therapy. J Subst Abuse Treat. 2013 Nov-Dec;45(5):451-6. doi: 10.1016/j.jsat.2013.06.004. Epub 2013 Jul 23.
PubMed 23891461Strong DR, Brown RA, Sims M, Herman DS, Anderson BJ, Stein MD. Persistence on a stress-challenge task before initiating buprenorphine treatment was associated with successful transition from opioid use to early abstinence. J Addict Med. 2012 Sep;6(3):219-25. doi: 10.1097/ADM.0b013e31825d927f.
PubMed 22864399Tsui JI, Herman DS, Kettavong M, Anderson BJ, Stein MD. Escitalopram is associated with reductions in pain severity and pain interference in opioid dependent patients with depressive symptoms. Pain. 2011 Nov;152(11):2640-2644. doi: 10.1016/j.pain.2011.08.011. Epub 2011 Sep 15.
PubMed 21924552Tsui JI, Herman DS, Kettavong M, Anderson BJ, Stein MD. Chronic pain and hepatitis C virus infection in opioid dependent injection drug users. J Addict Dis. 2011 Apr;30(2):91-7. doi: 10.1080/10550887.2011.554775.
PubMed 21491290Stein MD, Herman DS, Kettavong M, Cioe PA, Friedmann PD, Tellioglu T, Anderson BJ. Antidepressant treatment does not improve buprenorphine retention among opioid-dependent persons. J Subst Abuse Treat. 2010 Sep;39(2):157-66. doi: 10.1016/j.jsat.2010.05.014. Epub 2010 Jul 3.
PubMed 20598836
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antidepressants During Office-Based Buprenorphine
- ClinicalTrials.gov ID
- NCT00475878
- Acronym / sponsor ID
- DA022207
- Conditions
- Opiate Dependence, Depression
- Keywords
- opiate use, depression, buprenorphine, escitalopram
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Posted 3 Apr 2012
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 treatment of depressive symptoms using escitalopram improves adherence to Buprenorphine and reduces symptoms of depression for individuals receiving Buprenorphine through their medical provider.
Detailed description
Participants interested in receiving Buprenorphine will be offered the opportunity to enroll in this study. Enrolled study participants will complete interviews at baseline and again every two weeks for a total of 8 interviews over 3 months. In this double-blind randomized controlled trial, participants will either receive a placebo or escitalopram (10mg). All participants will also be followed by their Buprenorphine clinic medical provider. Questions during the face-to-face interviews will assess mood, drug craving, pain, sleep, medication adherence and drug-related experiences. Comparison(s): Participants randomized into the medication component of the study as compared to participants randomized into the placebo component of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| escitalopram | Active comparator | Drug: escitalopram |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- opiate dependence
- Ham-D > 14
Key exclusion criteria (4 listed)
- no psychiatric contraindications to using escitalopram
- no medical contraindications to using escitalopram
- methadone dose < 30
- no current SSRI use
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 |
|---|---|---|
| escitalopram10mg escitalopram/day for 3 months | Drug | escitalopram |
| placeboplacebo capsule/day for 3 months | Drug | placebo |
Primary outcome
Percentage of Participants Who Dropped Out of Buprenorphine Treatment
Time frame: 3 months
Drop-out is defined as 7 or more days of missed Buprenorphine doses
1 secondary outcome
Depressive Symptoms
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24521036Tsui JI, Anderson BJ, Strong DR, Stein MD. Craving predicts opioid use in opioid-dependent patients initiating buprenorphine treatment: a longitudinal study. Am J Drug Alcohol Abuse. 2014 Mar;40(2):163-9. doi: 10.3109/00952990.2013.848875. Epub 2014 Feb 12.
- Derived from this study: PubMed 23891461Cioe PA, Anderson BJ, Stein MD. Change in symptoms of erectile dysfunction in depressed men initiating buprenorphine therapy. J Subst Abuse Treat. 2013 Nov-Dec;45(5):451-6. doi: 10.1016/j.jsat.2013.06.004. Epub 2013 Jul 23.
- Derived from this study: PubMed 22864399Strong DR, Brown RA, Sims M, Herman DS, Anderson BJ, Stein MD. Persistence on a stress-challenge task before initiating buprenorphine treatment was associated with successful transition from opioid use to early abstinence. J Addict Med. 2012 Sep;6(3):219-25. doi: 10.1097/ADM.0b013e31825d927f.
- Derived from this study: PubMed 21924552Tsui JI, Herman DS, Kettavong M, Anderson BJ, Stein MD. Escitalopram is associated with reductions in pain severity and pain interference in opioid dependent patients with depressive symptoms. Pain. 2011 Nov;152(11):2640-2644. doi: 10.1016/j.pain.2011.08.011. Epub 2011 Sep 15.
- Derived from this study: PubMed 21491290Tsui JI, Herman DS, Kettavong M, Anderson BJ, Stein MD. Chronic pain and hepatitis C virus infection in opioid dependent injection drug users. J Addict Dis. 2011 Apr;30(2):91-7. doi: 10.1080/10550887.2011.554775.
- Derived from this study: PubMed 20598836Stein MD, Herman DS, Kettavong M, Cioe PA, Friedmann PD, Tellioglu T, Anderson BJ. Antidepressant treatment does not improve buprenorphine retention among opioid-dependent persons. J Subst Abuse Treat. 2010 Sep;39(2):157-66. doi: 10.1016/j.jsat.2010.05.014. Epub 2010 Jul 3.
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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, M.D. 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 3 study testing escitalopram in people with Opiate Dependence and Depression, 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 2 inclusion and 4 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 3 Apr 2012. 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 3 Apr 2012). 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?
Percentage of Participants Who Dropped Out of Buprenorphine Treatment (time frame: 3 months). 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 NCT00475878, which also lists 6 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 3 Apr 2012; AzTrials last refreshed its copy on 28 Oct 2026.