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

University of Sao Paulo General Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Cocaine Use Disorder; Crack Abuse or Dependence

Treatments: Drug: clonazepam 0,25 mg; Drug: clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07313371

86251324.2.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups

Control

Active Comparator group

Description:

Clonazepam 0,25 mg

Treatment:

Drug: clonazepam 0,25 mg

Intervention

Experimental group

Description:

Clonidine 0,1 mg

Treatment:

Drug: clonidine