To compare a drug N-Acetylcysteine (NAC) and Baclofen in reducing cannabis craving and use among patients diagnosed with Cannabis Use Disorder (CUD) and comorbid psychosis.

N-Acetylcysteine vs Baclofen as an anti craving agent in patients of Cannabis use Disorder with psychosis- A Randomised control trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079078

Enrollment

Registered

2025-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: F122- Cannabis dependence

Interventions

Intervention1: BACLOFEN: Baclofen, titrated to a dosage of 20 mg thrice daily for a duration of 3months. Control Intervention1: N-ACETYLCYSTEINE: N-Acetylcysteine, titrated to a dosage of 1200 mg twic

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18-65 years. 2. Diagnosed with Cannabis Use Disorder (CUD) and comorbid psychosis in remission diagnosed according to DSM-5 criteria. 3. Psychosis in remission determined by BPRS score less than 31.

Exclusion criteria

Exclusion criteria: 1. Severe medical conditions or neurological illness impacting study participation. (CVA, Epilepsy) 2. Concurrent use of other psychotropic substances that could interfere with the study. (Except Nicotine) 3. History of hypersensitivity to N-Acetylcysteine (NAC) or Baclofen.

Design outcomes

Primary

Measure	Time frame
Reduction in the scores in obsessive compulsive drug use scale for cannabis oven a 12 week periodTimepoint: Reduction in the scores in obsessive compulsive drug use scale for cannabis oven a 12 week period	—

Secondary

Measure	Time frame
The difference in Weekly Cannabis Use Frequency & THC-COOH Levels: 1. This involves measuring the changes in self-reported frequency of cannabis use & the levels of THC-COOH in urine . Percentage of participants in each group who have a negative urine drug screen for cannabis at the end of the studyTimepoint: The difference in Weekly Cannabis Use Frequency & THC-COOH Levels: 1. This involves measuring the changes in self-reported frequency of cannabis use & the levels of THC-COOH in urine . Percentage of participants in each group who have a negative urine drug screen for cannabis at the end of the study after 12 weeks;Changes in psychotic symptoms using the Brief Psychiatric Rating Scale (BPRS).Timepoint: Changes in psychotic symptoms using the Brief Psychiatric Rating Scale (BPRS) after 12 weeks.;The number of participants who discontinue treatment due to adverse events. 5. Significant changes in vital signs (such as blood pressure, heart rate) & laboratory test results (like liver function tests, & complete blood count) Timepoint: The number of participants who discontinue treatment due to adverse events. 5. Significant changes in vital signs (such as blood pressure, heart rate) & laboratory test results (like liver function tests, & complete blood count)	—

Measure

Time frame

The difference in Weekly Cannabis Use Frequency & THC-COOH Levels: 1. This involves measuring the changes in self-reported frequency of cannabis use & the levels of THC-COOH in urine . Percentage of participants in each group who have a negative urine drug screen for cannabis at the end of the studyTimepoint: The difference in Weekly Cannabis Use Frequency & THC-COOH Levels: 1. This involves measuring the changes in self-reported frequency of cannabis use & the levels of THC-COOH in urine . Percentage of participants in each group who have a negative urine drug screen for cannabis at the end of the study after 12 weeks;Changes in psychotic symptoms using the Brief Psychiatric Rating Scale (BPRS).Timepoint: Changes in psychotic symptoms using the Brief Psychiatric Rating Scale (BPRS) after 12 weeks.;The number of participants who discontinue treatment due to adverse events. 5. Significant changes in vital signs (such as blood pressure, heart rate) & laboratory test results (like liver function tests, & complete blood count) Timepoint: The number of participants who discontinue treatment due to adverse events. 5. Significant changes in vital signs (such as blood pressure, heart rate) & laboratory test results (like liver function tests, & complete blood count)

—

Countries

India

Contacts

Public ContactDr Shounak Pal

Kalinga Institute of Medical Sciences

drpranab@outlook.com9938833148

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026