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

NCT ID: NCT07313371

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-02-28

Brief Summary

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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

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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

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Cocaine Use Disorder Crack Abuse or Dependence

Keywords

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crack cocaine craving

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Clonazepam 0,25 mg

Group Type ACTIVE_COMPARATOR

clonazepam 0,25 mg

Intervention Type DRUG

clonazepam 0,25 mg bid

Intervention

Clonidine 0,1 mg

Group Type EXPERIMENTAL

clonidine

Intervention Type DRUG

Clonidine 0,1 mg bid

Interventions

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clonidine

Clonidine 0,1 mg bid

Intervention Type DRUG

clonazepam 0,25 mg

clonazepam 0,25 mg bid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dângela Layne Silva Lassi

Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dangela L S Lassi

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Central Contacts

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Dangela Lassi

Role: CONTACT

Phone: +551138032802

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 35448887 (View on PubMed)

Related Links

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https://www.unodc.org/unodc/data-and-analysis/world-drug-report-2022.html

United Nations Office on Drugs and Crime. Treatment of Stimulant Use Disorders: Current Practices and Promising Perspectives.

https://nida.nih.gov/publications/drugs-brains-behavior-science-addiction/drug-misuse-addiction

Drug Misuse and Addiction. National Institute on Drug Abuse website

Other Identifiers

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86251324.2.0000.0068

Identifier Type: -

Identifier Source: org_study_id