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

NCT07313371 | Recruiting Phase 4

• 1 other identifier: 86251324.2.0000.0068
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Use Disorder; Crack Abuse or Dependence

Keywords

crack; cocaine; craving

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  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 Outcomes (6)

• Adverse Effects

  from the beginning of the intervention to 90 days after enrollment in the study

• Blood pressure

  Three times daily from baseline up to 14 days

• Heart Rate

  Three times daily from baseline up to 14 days

• Cinical Global Impression - Severity of Illness (CGI-S)

  At baseline

• Clinical Global Impression - Improvement (CGI-I)

  Will be assessed after 1 and 2 weeks from baseline

Study Arms (2)

Control

ACTIVE COMPARATOR

Clonazepam 0,25 mg

Drug: clonazepam 0,25 mg

Intervention

EXPERIMENTAL

Clonidine 0,1 mg

Drug: clonidine

Interventions

clonidine DRUG

Clonidine 0,1 mg bid

Intervention

clonazepam 0,25 mg DRUG

clonazepam 0,25 mg bid

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto Perdizes

São Paulo, São Paulo, 05021-001, Brazil

RECRUITING

Related Publications (1)

• Roque Bravo R, Faria AC, Brito-da-Costa AM, Carmo H, Mladenka P, Dias da Silva D, Remiao F, On Behalf Of The Oemonom Researchers. Cocaine: An Updated Overview on Chemistry, Detection, Biokinetics, and Pharmacotoxicological Aspects including Abuse Pattern. Toxins (Basel). 2022 Apr 13;14(4):278. doi: 10.3390/toxins14040278.

  PMID: 35448887 BACKGROUND

Related Links

• United Nations Office on Drugs and Crime. Treatment of Stimulant Use Disorders: Current Practices and Promising Perspectives.
• Drug Misuse and Addiction. National Institute on Drug Abuse website

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dangela Lassi

  University of São Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dangela Lassi

CONTACT

+551138032802; dangela.lassi@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 31, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

BR (1)