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

NCT01949571 | Completed Phase 2 DMC

• 1 other identifier: INPRF-01-MIR
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-withdrawal.; Drug Abuse; Drug-induced Depressive State; AOD Craving; AODR Depressive State

Keywords

Mirtazapine.; Addiction.; Cocaine.; Cocaine-craving.; Cocaine-withdrawal

Outcome Measures

Primary Outcomes (1)

• Evidence that Mirtazapine attenuates cocaine-craving.

  Four years

Study Arms (1)

Mirtazapine

EXPERIMENTAL

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)

Interventions

Mirtazapine (REMERON, Schering-Plough-Organon) DRUG

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.

Also known as: MIR

Mirtazapine

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente: lead

Study Sites (1)

National Institute of Psychiatry

Mexico City, Mexico City, 14370, Mexico

Location

Related Publications (3)

• Afshar M, Knapp CM, Sarid-Segal O, Devine E, Colaneri LS, Tozier L, Waters ME, Putnam MA, Ciraulo DA. The efficacy of mirtazapine in the treatment of cocaine dependence with comorbid depression. Am J Drug Alcohol Abuse. 2012 Mar;38(2):181-6. doi: 10.3109/00952990.2011.644002. Epub 2012 Jan 5.

  PMID: 22221171 BACKGROUND

• Zueco Perez PL. [Mirtazapine in the treatment of cocaine-dependence in patients with methadone]. Actas Esp Psiquiatr. 2002 Nov-Dec;30(6):337-42. Spanish.

  PMID: 12487943 BACKGROUND

• Graves SM, Rafeyan R, Watts J, Napier TC. Mirtazapine, and mirtazapine-like compounds as possible pharmacotherapy for substance abuse disorders: evidence from the bench and the bedside. Pharmacol Ther. 2012 Dec;136(3):343-53. doi: 10.1016/j.pharmthera.2012.08.013. Epub 2012 Aug 29.

  PMID: 22960395 BACKGROUND

MeSH Terms

Conditions

Substance Withdrawal Syndrome; Substance-Related Disorders; Behavior, Addictive

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Benito Antón-Palma, MD-PhD

  National Institute of Psychiatry

  STUDY DIRECTOR

• Ricardo Nanni-Alvarado, Psychiatry

  National Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador en Ciencias Médicas "F".

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: September 24, 2013
• Study Start: January 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2012
• Last Updated: September 24, 2013

Record last verified: 2013-09

Locations

ME (1)