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| Sponsored by: |
Rhode Island Hospital |
|---|---|
| Information provided by: | Rhode Island Hospital |
| ClinicalTrials.gov Identifier: | NCT00475878 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Opiate Dependence Depression |
Drug: escitalopram Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Antidepressants During Office-Based Buprenorphine |
| Estimated Enrollment: | 182 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | April 2009 |
| Arms | Assigned Interventions |
|---|---|
| placebo: Placebo Comparator |
Drug: placebo
placebo capsule/day for 3 months
|
| escitalopram: Active Comparator |
Drug: escitalopram
10mg escitalopram/day for 3 months
|
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. Participants will be compensated for their time. Comparison(s): Participants randomized into the medication component of the study as compared to participants randomized into the placebo component of the study.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michael D Stein, MD | 401-444-3830 | mstein@lifespan.org |
| Contact: Debra S Herman, Ph.D. | 401-444-7912 | dherman@lifespan.org |
| United States, Rhode Island | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Principal Investigator: Michael D Stein, M.D. | |
| Principal Investigator: | Michael D Stein, M.D. | Rhode Island Hospital |
More Information
| Responsible Party: | RI Hospital ( Michael Stein, M.D./Principal Investigator ) |
| Study ID Numbers: | DA022207, 4102-06 |
| Study First Received: | May 18, 2007 |
| Last Updated: | December 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00475878 |
| Health Authority: | United States: Institutional Review Board |
|
opiate use depression buprenorphine escitalopram |
|
Buprenorphine Depression Mental Disorders Substance-Related Disorders Mood Disorders Disorders of Environmental Origin |
Dexetimide Opioid-Related Disorders Depressive Disorder Citalopram Serotonin Behavioral Symptoms |
|
Parasympatholytics Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Narcotic Antagonists Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Sensory System Agents Therapeutic Uses |
Analgesics Antidepressive Agents, Second-Generation Antidepressive Agents Analgesics, Opioid Central Nervous System Depressants Narcotics Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |
