CompletedPhase 2

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

Mexico64 participantsStarted 2007-01

Plain-language 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.

Who can participate

Age range

14 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evidence that Mirtazapine attenuates cocaine-craving.

Timeframe: Four years

Trial details

NCT IDNCT01949571

SponsorInstituto Nacional de Psiquiatría Dr. Ramón de la Fuente

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-07

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