Cannabis use disorder. Cannabis dependence
Conditions
Interventions
Intervention 1: Intervention group: Extended brief intervention adjunct to saffron (Crocus sativus) capsules 30 mg twice daily for six weeks. Intervention 2: Control group: Extended brief intervention
Sponsors
Iran National Science Foundation
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Able to give informed consent according to GCP guidelines. Having a Diagnostic and Statistical Manual of Mental Disorders (DSM-V) diagnosis of cannabis use disorder of at least moderate severity (more than 4 symptoms) assessed by a psychiatrist with expertise in the field. Having a positive urine THC-COOH test. Being treatment-seeking and attending an outpatient clinic, meaning that the patient expressed a desire to stop using cannabis and intended to do so within the next month, based on the adapted Motivation To Stop Scale.
Exclusion criteria
Exclusion criteria: Having a substance use disorder according to DSM-V other than cannabis and nicotine use disorders. Positive urine test for a substance other than cannabis, including methamphetamine, cocaine, benzodiazepines, tricyclic antidepressants, barbituates, phencyclidine, amphetamines, morphine, and methadone. Recent use of synthetic cannabinoids. Hypersensitivity to saffron. Pregnancy, breastfeeding, or intention to have children. Being treated for a substance use disorder, currently. Having a diagnosis of a psychotic disorder (past or present). Having any uncontrolled psychiatric or medical illness. Taking psychotropic medications during the study period. Occurrence of severe adverse events at any point in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cannabis use. Timepoint: Baseline and weeks 2, 4, 6, and 12. Method of measurement: Qualitative detection of THC-COOH in urine.;Cannabis use. Timepoint: Baseline and weeks 2, 4, 6, and 12. Method of measurement: Patient self-report of days abstinent from cannabis using Timeline Follow-back. | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimated cannabis grams. Timepoint: Baseline and weeks 2, 4, 6, and 12. Method of measurement: Estimated average daily cannabis use (with participant reporting, along with standardization of units and calculation by the interviewer).;Severity of withdrawal symptoms. Timepoint: Baseline and weeks 2, 4, 6, and 12. Method of measurement: By using the Cannabis Withdrawal Scale.;Smoking cigarettes. Timepoint: Baseline and weeks 2, 4, 6, and 12. Method of measurement: Patient self-report of the average number of cigarettes smoked per day using Timeline Follow-back.;Depression severity. Timepoint: Baseline and weeks 2, 4, 6, and 12. Method of measurement: By using the Montgomery–Åsberg Depression Rating Scale.;Side effects. Timepoint: Baseline and weeks 2, 4, 6, and 12. Method of measurement: Using a general checklist of 25 items including possible complications of the intervention with the possibility of adding complications other than those listed, recording the severity of each reported complication. One week after the start of the intervention, participants will be contacted to review any side effects that require intervention. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAhmad Shamabadi
Tehran University of Medical Sciences
Outcome results
None listed