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NCT Number: NCT07313371

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

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.

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Key information

Conditions

Cocaine Use Disorder Crack Abuse or Dependence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clonidine

Drug

Clonidine 0,1 mg bid

clonazepam 0,25 mg

Drug

clonazepam 0,25 mg bid

Primary outcomes

  1. 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

Secondary outcomes

  1. Adverse Effects

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

    Spontaneous reports

  2. Blood pressure

    Time frame: Three times daily from baseline up to 14 days

    Diastolic and systolic pressure in mmHg

  3. Heart Rate

    Time frame: Three times daily from baseline up to 14 days

    Heart rate in beats per minute

  4. 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)

  5. 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)

  6. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Dangela Lassi

CONTACT

[email protected]

+551138032802

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 31, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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