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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01165541
First received: July 16, 2010
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Alcohol Dependence
Drug: Mirtazapine
Drug: Quetiapine fumarate extended release (Quetiapine XR)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Sequential Study of Quetiapine Fumarate Extended Release (XR) and Mirtazapine for the Treatment of Alcohol Dependency in Very Heavy Drinkers

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Number of Very Heavy Drinking Days Per Week [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 20
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Quetiapine fumarate extended release (Quetiapine XR)
Quetiapine XR 50-400mg
Drug: Quetiapine fumarate extended release (Quetiapine XR)
Quetiapine fumarate extended release 50-400mg/d
Other Name: quetiapine XR, Seroquel XR
Experimental: Quetiapine XR and Mirtazapine
Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg
Drug: Mirtazapine
mirtazapine (7.5-45mg)
Other Name: mirtazapine (Remeron)
Drug: Quetiapine fumarate extended release (Quetiapine XR)
Quetiapine fumarate extended release 50-400mg/d
Other Name: quetiapine XR, Seroquel XR

Detailed Description:

Alcohol dependence is a debilitating illness affecting almost 8 million people annually and for which the current FDA approved medications are only modestly effective in reducing relapse or drinking. Because alcohol dependence is such a common, devastating disease, researchers continue to search for new treatments that could be more effective and better tolerated. The development and testing of medications that target brain systems involved in alcohol dependence is of acute interest to patients, clinicians and researchers.

Studies by our group in animals have suggested that medications with a combination of a weak dopamine D2 receptor antagonism, a potent norepinephrine alpha 2 receptor antagonism, and norepinephrine reuptake inhibition decrease alcohol drinking. Quetiapine is a weak D2 antagonist and a moderate alpha 2 receptor antagonist, and its primary metabolite, desalkylquetiapine, is a norepinephrine reuptake inhibitor, this medication is likely to have some ability to decrease alcohol drinking. But, when combined with mirtazapine, a potent alpha 2 antagonist, the combination should potently decrease alcohol drinking. The proposed study is based on this theoretical formulation, as well as on clinical studies of quetiapine and mirtazapine used independently.

This is an open-label, sequential design study with one group of approximately 20 subjects studied under two treatment conditions; quetiapine alone and quetiapine + mirtazapine. The primary objective is to assess the efficacy of quetiapine fumarate extended-release (XR) alone vs. quetiapine fumarate XR in combination with mirtazapine in reducing the weekly percentage of days of heavy drinking (5 or more drinks per drinking day for men, 4 or more drinks per drinking day for women) in subjects meeting DSM-IV criteria for alcohol dependency.

Participants will begin with quetiapine fumarate XR up to a target dose of 400 mg and will receive 16 weeks of treatment with quetiapine. At week 8 subjects will begin 9 weeks of mirtazapine added to their existing regimen of quetiapine treatment. Participants will also meet with a medical provider at each visit to encourage compliance with study medication and attending study visits, review adverse events, and set goals for reduction of drinking. Analyses will assess whether treatment with quetiapine in combination with mirtazapine reduces drinking more than treatment with quetiapine alone.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-64
  2. The subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for alcohol dependence
  3. The subject is seeking treatment for alcohol dependence and desires a reduction or cessation of drinking
  4. 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?
  5. If the subject is female and of child bearing potential, she agrees to use an acceptable method of birth control.
  6. The subject is able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits.
  7. The subject is able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
  8. The subject has a breath alcohol concentration (BAC) equal to 0.000 on s/he signing the informed consent document.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165541

Locations
United States, New Hampshire
Dartmouth Medical School Department of Psychiatry's Addition Research Center
Bedford, New Hampshire, United States, 03110
Dartmouth Medical School Department of Psychiatry's Addiction Research Center
Hanover, New Hampshire, United States, 03755
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Mary Brunette, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01165541     History of Changes
Other Study ID Numbers: QM1
Study First Received: July 16, 2010
Results First Received: December 19, 2013
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Mianserin
Mirtazapine
Quetiapine
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014