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

February 20, 2026 updated by: Dângela Layne Silva Lassi, University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05021-001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Clonazepam 0,25 mg
Drug: clonazepam 0,25 mg
clonazepam 0,25 mg bid
Experimental: Intervention
Clonidine 0,1 mg
Drug: clonidine
Clonidine 0,1 mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: Daily from enrollment to end of treatment at 2 weeks; then after 30, 60 and 90 days after end of treatment
Visual Analog Scale for craving, ranging from 0 to 10, where 0 means no craving and 10 means maximum craving
Daily from enrollment to end of treatment at 2 weeks; then after 30, 60 and 90 days after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Effects
Time Frame: from the beginning of the intervention to 90 days after enrollment in the study
Spontaneous reports
from the beginning of the intervention to 90 days after enrollment in the study
Blood pressure
Time Frame: Three times daily from baseline up to 14 days
Diastolic and systolic pressure in mmHg
Three times daily from baseline up to 14 days
Heart Rate
Time Frame: Three times daily from baseline up to 14 days
Heart rate in beats per minute
Three times daily from baseline up to 14 days
Cinical Global Impression - Severity of Illness (CGI-S)
Time Frame: At baseline
The Clinical Global Impression - Severity of Illness (CGI-S) is a brief, clinician-rated scale used to assess the current severity of a patient's mental illness at the time of assessment, ranging from 1 (1 Normal, not at all ill) to 7 (Among the most extremely ill patients)
At baseline
Clinical Global Impression - Improvement (CGI-I)
Time Frame: Will be assessed after 1 and 2 weeks from baseline
The Clinical Global Impression - Improvement (CGI-I) scale is a single-item, clinician-rated assessment tool used to measure the change in a patient's overall clinical condition since the baseline, ranging from 1 (very much improved) to 7 (Very much worse)
Will be assessed after 1 and 2 weeks from baseline
Crack/Cocaine Use
Time Frame: 30, 60 and 90 days after the end of the intervention
The Timeline Followback (TFLB) will be used to measure the patient's average daily drug use in standardized units (e.g. Units, grams, or rocks of cocaine/crack)
30, 60 and 90 days after the end of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Dangela Lassi, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 16, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 86251324.2.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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