NCT07313371

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: a Randomized Clinical Trial.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cocaine Use Disorder
• Crack Abuse or Dependence

Interventions

Type	Name	Description
DRUG	clonidine	Clonidine 0,1 mg bid
DRUG	clonazepam 0,25 mg	clonazepam 0,25 mg bid

Timeline

• Start date: 2026-01-28
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2025-12-31
• Last updated: 2026-02-24

Locations

1 site across 1 country: Brazil