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Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder

Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder

Recruiting
18-65 years
All
Phase 4

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Overview

This is a single-center, randomized intervention study in a volunteer population of patients with cocaine/crack use disorder to evaluate the pharmacological treatment of cocaine/crack craving, comparing the drug clonidine with the active placebo clonazepam.

Description

Patients included will be administered clonidine 0.1 mg every 12 hours or clonazepam 0.25 mg every 12 hours for the first 2 weeks of treatment, followed by a washout for the final 2 weeks. The medication will be administered under the supervision of a member of the nursing staff. Patients will be monitored with vital signs three times a day to track changes that may be caused by the medication, such as reduced heart rate and hypotension. The primary outcome measure will be the change in cocaine craving at admission and two weeks after the start of treatment, using the visual analog scale.

Eligibility

Inclusion Criteria:

  • Patients hospitalized in the adult Alcohol and Drugs ward of the Perdizes Institute (IPer) at the Hospital das Clínicas, University of São Paulo Medical School
  • DSM-5 criteria for cocaine and/or crack use disorder
  • Voluntarily seeking treatment
  • Must be able to swallow pills

Exclusion Criteria:

  • Inability to read and/or understand the study questionnaires
  • benzodiazepine use disorder
  • opioid use disorder
  • alcohol use disorder

Study details
    Cocaine Use Disorder
    Crack Abuse or Dependence

NCT07313371

University of Sao Paulo General Hospital

14 May 2026

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