A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency

NCT01165541 | Completed Phase 2 Results DMC

• 1 other identifier: QM1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to test whether taking two medicines (quetiapine and mirtazapine) is better for helping people to decrease drinking than taking one medicine alone (quetiapine).

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

• Number of Very Heavy Drinking Days Per Week

  The number of "very heavy" drinking days (8 or more drinks per drinking day for men or 6 or more drinks per drinking day for women) per week

  14 Weeks

Study Arms (2)

Quetiapine fumarate extended release (Quetiapine XR)

ACTIVE COMPARATOR

Quetiapine XR 50-400mg

Drug: Quetiapine fumarate extended release (Quetiapine XR)

Quetiapine XR and Mirtazapine

EXPERIMENTAL

Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg

Drug: Mirtazapine; Drug: Quetiapine fumarate extended release (Quetiapine XR)

Interventions

Mirtazapine DRUG

mirtazapine (7.5-45mg)

Also known as: mirtazapine (Remeron)

Quetiapine XR and Mirtazapine

Quetiapine fumarate extended release (Quetiapine XR) DRUG

Quetiapine fumarate extended release 50-400mg/d

Also known as: quetiapine XR, Seroquel XR

Quetiapine XR and Mirtazapine; Quetiapine fumarate extended release (Quetiapine XR)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-64
• The subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for alcohol dependence
• The subject is seeking treatment for alcohol dependence and desires a reduction or cessation of drinking
• The subject is able to verbalize understanding of the consent form, able to provide written informed consent, and able to verbalize willingness to complete study procedures?
• If the subject is female and of child bearing potential, she agrees to use an acceptable method of birth control.
• The subject is able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits.
• The subject is able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
• The subject has a breath alcohol concentration (BAC) equal to 0.000 on s/he signing the informed consent document.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (2)

Dartmouth Medical School Department of Psychiatry's Addition Research Center

Bedford, New Hampshire, 03110, United States

Location

Dartmouth Medical School Department of Psychiatry's Addiction Research Center

Hanover, New Hampshire, 03755, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Mary Brunette, MD
• Organization: Geisel School of Medicine At Dartmouth

mary.brunette@dartmouth.edu

603-271-7642

Study Officials

• Mary Brunette, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 20, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 9, 2018
• Results First Posted: March 31, 2014

Record last verified: 2018-03

Locations

US (2)