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Comparison of the efficacy and safety of oxazepam and diazepam in the treatment of acute withdrawal symptoms of alcohol dependence A multicenter practical randomized controlled study (pRCT)

Comparison of the efficacy and safety of oxazepam and diazepam in the treatment of acute withdrawal symptoms of alcohol dependence A multicenter practical randomized controlled study (pRCT)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118157
Enrollment
Unknown
Registered
2026-02-02
Start date
2026-02-04
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AWS

Interventions

Diazepam group:Patients in the diazepam group were treated with oral diazepam, following the fixed dosing regimen until the CIWA-Ar score was <=8 points, and then the medication was stopped.administra
The oxazepam group:Patients in the oxazepam group were treated with oral oxazepam, following the fixed dosing regimen until the CIWA-Ar score was <=8 points, and then the medication was stopped.

Sponsors

The Second Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Inpatients; Aged 18 to 70; 2. Meet four or more of the DSM-5 diagnostic criteria for alcohol use disorder; 3. Currently in the withdrawal period with a CIWA-Ar score of >=16 points; 4. The doctor assesses that benzodiazepines are suitable for treatment. 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combined with other substance dependencies (except nicotine); 2. Impact assessment of severe mental disorders or cognitive impairments; 3. Pregnancy or lactation period; 4. Allergic to or contraindicated to the investigational drug; 5. ALT or AST>500; 6. New York Cardiac Rating (NYHA) rating >= level 3; 7. Patients with a history of HIV infection or autoimmune deficiency; 8. Inability to cooperate with follow-up or deemed inappropriate by the researcher.

Design outcomes

Primary

MeasureTime frame
Change in CIWA-Ar score and time to reach a score of <=8;

Secondary

MeasureTime frame
Trends in liver function indicators;

Countries

China

Contacts

Public ContactHao Wei

The Second Xiangya Hospital, Central South University

1945917911@qq.com+86 177 0408 9454

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026