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Clinical Studies on the Therapeutic Effects of Mirtazapine on Drug-craving in Cocaine Addicts. (MADC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01949571
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : September 24, 2013
Information provided by (Responsible Party):
Dr Benito Antón Palma, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Brief Summary:

INTRODUCTION. One of the main problems of the treatment of cocaine-dependent patients is the high rate of relapses occurs within the first months after detoxification. In the early withdrawal phase, patients suffer severe anxious depressive symptoms, known in the argot as crash, which occurs in parallel with an appetite overflowed by re-experiencing the effects of the substance, known as craving. Most of the times, these clinical symptoms act as negative reinforcement, which can be severe enough to induce a drug-relapse that greatly hampers the treatment.

TYPE OF STUDY randomized, double-blind, placebo-experimental. GENERAL PURPOSE To determine the efficacy of mirtazapine for the treatment of cocaine dependence. SPECIFIC OBJECTIVES 1) To evaluate the efficacy in the treatment of craving in individuals with cocaine dependence disorder treated with mirtazapine during acute withdrawal phase. 2) Determine the efficacy of reducing anxious depressive symptomatology (Crash) associated with acute withdrawal in subjects with cocaine dependence disorder treated with mirtazapine. 3) Evaluate the maintenance of abstinence in patients with cocaine dependence disorder treated with mirtazapine. 4) Determine the efficacy of mirtazapine in the treatment of subjects dependent on cocaine comorbid with major depressive disorder.

HYPOTHESIS For pharmacokinetics and pharmacodynamics mirtazapine contribute to the reduction in the intensity of withdrawal symptoms in cocaine dependent subjects by acting on the neurochemical circuitry involved in the reward-seeking behavior and has a prolonged effect anticraving. METHOD The attending physician outpatient identifies the Addiction Clinic of the National Institute of Psychiatry who meet the inclusion criteria and invite them to participate voluntarily. If patients accept, send them to the principal investigator for the start of the ratings. Demographics INSTRUMENTS, MINI structured interview, Anxiety and Depression Scale Beck Scale.

Condition or disease Intervention/treatment Phase
Drug-withdrawal. Drug Abuse Drug-induced Depressive State AOD Craving AODR Depressive State Drug: Mirtazapine (REMERON, Schering-Plough-Organon) Phase 2

Detailed Description:

Evaluation. Evaluation of cocaine craving was assessed weekly through the Cocaine Craving Questionnaire (CCQ-G) (43-46). The CCQ-G measures the desire or urge level for drug consumption throughout the 45 Likert items established in the Questionnaire. The Likert scale consisted of seven options ranging from 1 to 7. Indicating from the lowest number (1) complete disagree of questions asked/item and the highest number (7) complete agreement of questions answered/item. CCQ-G items were written in past tense, with the intention that participants could report their cocaine craving status (level) during the previous week. Main items in the CCQ-G used to assess cocaine craving defined as factors were; a). Elements that denote intense cocaine craving (factor 1); b). Items that related to the anticipation of positive results (factor 2); c). Anticipation of relief from drug-withdrawal symptoms (factor 3); and d). Items that perceived a lack of control over cocaine consumption, denoting the intention and planning for cocaine consumption (factor 4).

Each week patient were assessed about their psychopathological status through the Symptom Check List 90 (SCL-90-R) (47-50). The SCL-90 evaluate the psychological degree of "distress" shown by a subject through 90 Likert-type reagents, ranging from 0 up to 4, and grouped into nine dimensions, which include, somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism.

Statistical Analysis.

Data were expressed, as mean ± SEM. To determinate the differences in score between groups over time, the data were then analyzed by a two-way repeated measures ANOVA with time (week) as the repeated measure. If there was a significant interaction between time and treatment, we then performed a Tukey's post-hoc test to detect significant differences between each one of the factors at each experimental phase. Comparisons between mean score obtained during each phase were analyzed by a two-way ANOVA (treatment x phase) followed by Tukey's test for post-hoc comparisons. The level of statistical significance was set at p < 0.05.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Phase II Clinical Studies on Anti-addictive Therapeutic Effects of Mirtazapine in Human Subjects Addicted to Cocaine.
Study Start Date : January 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mirtazapine
During the first and second phase of the study, subjects assigned to the control group received one tablet of placebo under daily basis, whereas the mirtazapine group received 30 mg of mirtazapine daily. During the third phase, placebo group received same tablet under daily basis, whereas the mirtazapine group received 15 mg of mirtazapine.
Drug: Mirtazapine (REMERON, Schering-Plough-Organon)
During the first and second phase of the study,the mirtazapine group received 30 mg of mirtazapine daily. During the third phase, the mirtazapine group received 15 mg of mirtazapine.
Other Name: MIR

Primary Outcome Measures :
  1. Evidence that Mirtazapine attenuates cocaine-craving. [ Time Frame: Four years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Who can read and write. Meet the DSM IV TR criteria for substance dependence disorder (Snuff, cocaine, ethanol and polysubstance.). That meet the ratings.

Exclusion Criteria:

disorder subjects with a history of dependency that are not abstinent (³. 1 month). Subjects with a history of neurological diseases. Subjects with general medical illness (eg CVD, hypertension, DM). Subjects prior to the implementation of neurocognitive testing report having consumed coffee, tea, alcohol or smoked three hours conducting assessments. Subjects who take more than 3 prescription drugs. Those who report being too tired. Subjects who report not having made an effort to answer the tests.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01949571

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National Institute of Psychiatry
México. Distrito Federal, Distrito Federal, Mexico, 14370
Sponsors and Collaborators
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
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Study Director: Benito Antón-Palma, MD-PhD National Institute of Psychiatry
Principal Investigator: Ricardo Nanni-Alvarado, Psychiatry National Institute of Psychiatry

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Responsible Party: Dr Benito Antón Palma, Investigador en Ciencias Médicas "F"., Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente Identifier: NCT01949571    
Other Study ID Numbers: INPRF-01-MIR
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013
Keywords provided by Dr Benito Antón Palma, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente:
Additional relevant MeSH terms:
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Substance-Related Disorders
Substance Withdrawal Syndrome
Chemically-Induced Disorders
Mental Disorders
Behavioral Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Anxiety Agents
Tranquilizing Agents
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists