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

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ClinicalTrials.gov Identifier: NCT01949571
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : September 24, 2013
Sponsor:
Information provided by (Responsible Party):
Dr Benito Antón Palma, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Tracking Information
First Submitted Date  ICMJE September 20, 2013
First Posted Date  ICMJE September 24, 2013
Last Update Posted Date September 24, 2013
Study Start Date  ICMJE January 2007
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2013)
Evidence that Mirtazapine attenuates cocaine-craving. [ Time Frame: Four years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Studies on the Therapeutic Effects of Mirtazapine on Drug-craving in Cocaine Addicts.
Official Title  ICMJE Phase II Clinical Studies on Anti-addictive Therapeutic Effects of Mirtazapine in Human Subjects Addicted to Cocaine.
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Drug-withdrawal.
  • Drug Abuse
  • Drug-induced Depressive State
  • AOD Craving
  • AODR Depressive State
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Mirtazapine (REMERON, Schering-Plough-Organon)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2013)
64
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01949571
Other Study ID Numbers  ICMJE INPRF-01-MIR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Benito Antón Palma, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Study Sponsor  ICMJE Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Benito Antón-Palma, MD-PhD National Institute of Psychiatry
Principal Investigator: Ricardo Nanni-Alvarado, Psychiatry National Institute of Psychiatry
PRS Account Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP