SSRI and Buprenorphine

NCT ID: NCT00475878

Last Updated: 2012-04-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Opiate Dependence Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo capsule/day for 3 months

escitalopram

Group Type ACTIVE_COMPARATOR

escitalopram

Intervention Type DRUG

10mg escitalopram/day for 3 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

escitalopram

10mg escitalopram/day for 3 months

Intervention Type DRUG

placebo

placebo capsule/day for 3 months

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* opiate dependence
* Ham-D \> 14

Exclusion Criteria

* no psychiatric contraindications to using escitalopram
* no medical contraindications to using escitalopram
* methadone dose \< 30
* no current SSRI use
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Stein, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael D Stein, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24521036 (View on PubMed)

Cioe 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.

Reference Type DERIVED
PMID: 23891461 (View on PubMed)

Strong 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.

Reference Type DERIVED
PMID: 22864399 (View on PubMed)

Tsui 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.

Reference Type DERIVED
PMID: 21924552 (View on PubMed)

Tsui 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.

Reference Type DERIVED
PMID: 21491290 (View on PubMed)

Stein 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.

Reference Type DERIVED
PMID: 20598836 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0807-002

Identifier Type: -

Identifier Source: secondary_id

DA022207

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Neurotrophic Factors and Depression
NCT00812994 COMPLETED PHASE4