Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
ID07313371

Efficacy of Clonidine in Reducing Craving in Inpatients With Cocaine and Crack Use Disorder: a Randomized Clinical Trial.

Led by University of Sao Paulo General Hospital · Updated on 2026-02-24

36

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of two medications, clonidine and clonazepam, on reducing cravings in patients with cocaine and crack use disorder. This randomized clinical trial focuses on inpatients who meet the diagnosis criteria for these disorders and are voluntarily seeking treatment. The study is conducted by the University of Sao Paulo General Hospital and aims to compare the craving reduction potential of clonidine against an active placebo, clonazepam. Participants will receive either clonidine 0.1 mg or clonazepam 0.25 mg every 12 hours for the first two weeks of the study. Medication will be given under nursing supervision, followed by a two-week washout period without medication. Vital signs will be monitored three times daily during the treatment phase to observe any medication-related changes such as heart rate or blood pressure alterations. During the study, patients will regularly complete assessments measuring cocaine craving using the Visual Analog Scale from enrollment through two weeks of treatment and at 30, 60, and 90 days after treatment ends. Additional evaluations include monitoring adverse effects, blood pressure, heart rate, and clinical impressions of illness severity and improvement. Cocaine and crack use will also be tracked up to 90 days post-treatment. The total duration of participation includes treatment and follow-up periods extending over several months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients hospitalized in the adult Alcohol and Drugs ward of the Perdizes Institute (IPer) at the Hospital das Cl�ednicas, University of S�e3o Paulo Medical School
  • Meet DSM-5 criteria for cocaine and/or crack use disorder
  • Voluntarily seeking treatment
  • Able to swallow pills
Not Eligible

You will not qualify if you...

  • Unable to read and/or understand the study questionnaires
  • Diagnosis of benzodiazepine use disorder
  • Diagnosis of opioid use disorder
  • Diagnosis of alcohol use disorder

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 weeks

Participants receive either clonidine 0.1 mg or clonazepam 0.25 mg every 12 hours for 2 weeks under nursing supervision. Vital signs are monitored three times daily to track medication effects.

Daily visits for up to 2 weeks with three daily vital sign checks

Follow-up

Duration - 90 days

Participants are followed for 90 days after treatment to assess craving levels, adverse effects, and substance use.

Visits at 30, 60, and 90 days after treatment

Trial Site Locations

Total: 1 location

1

Instituto Perdizes

São Paulo, São Paulo, Brazil, 05021-001

Actively Recruiting

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Research Team

D

Dangela Lassi

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Cocaine: An Updated Overview on Chemistry, Detection, Biokinetics, and Pharmacotoxicological Aspects including Abuse Pattern.

Rita Roque Bravo, Ana Carolina Faria, Andreia Machado Brito-da-Costa...

https://pubmed.ncbi.nlm.nih.gov/35448887