Cannabis Use Disorder
Conditions
Brief summary
A randomized controlled trial to assess the efficacy of extended-release guanfacine to reduce cannabis use frequency in young people with cannabis use disorder following a period of monitored abstinence.
Interventions
Target dose 4 mg daily
BEHAVIORALResidential withdrawal
4-14 days in residential withdrawal treatment
BEHAVIORALEngagement with alcohol and other drug services
Ongoing engagement with a youth drug and alcohol service for counselling or other support for the duration of the study
DRUGPlacebo
Placebo capsule taken daily
Sponsors
Youth Support and Advocacy Service
University of Melbourne
Orygen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1. 12-25 years of age (inclusive) at consent; 2. Seeking treatment for cannabis use; 3. DSM-5 Cannabis Use Disorder, mild, moderate or severe; 4. Self-reported cannabis use on average at least 5 days/week during the 28 days prior to screening with a THC positive urine drug screen on the day of screening; and 5. Able to provide informed consent (both adequate IQ and English fluency; \<18-year-olds will provide consent themselves in addition to parent/guardian consent).
Exclusion criteria
1. DSM-5 substance use disorder (moderate or severe) except cannabis or nicotine; 2. Any unstable medical, psychiatric or neurological condition or medical contraindicating study participation; 3. Diagnosis of a psychotic or bipolar illness; 4. Acute suicidality as assessed by clinician; 5. Prescribed antipsychotics, benzodiazepines or other sedative medications, or other medications for the treatment of ADHD. If prescribed antidepressants, the participant must have been on a stable dose for more than 2 weeks at screening; 6. A history of heart disease or cardiac risk factors (e.g. arrhythmias); 7. Abnormal liver or thyroid function as indicated by clinically-significant findings on blood tests; 8. Pregnancy, breast feeding or, if sexually active and able to become pregnant, no effective contraception. 9. Intention to enter residential rehabilitation after treatment in the YSAS residential withdrawal facility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - change from baseline in cannabis use frequency following monitored abstinence | Baseline and weekly in the 4 week outpatient phase immediately following discharge from residential withdrawal | Change from baseline in average frequency of cannabis use (days of use/week) in the 4 weeks immediately following discharge from residential withdrawal, assessed weekly using the Timeline Follow-Back. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food intake during residential withdrawal admission | Daily during residential treatment for 4 to 14 days | Measured with a food intake dairy |
| Treatment engagement (residential) | Baseline to end of treatment | Measured as the longest consecutive length of stay in residential withdrawal (4-14 days) |
| Treatment engagement (outpatient) | Baseline to end of treatment | Measured as the number of outpatient alcohol and other drug counselling sessions completed |
| Cannabis craving during residential withdrawal admission | Daily during residential treatment for 4 to 14 days | Measured with the Brief Substance Craving Scale - Cannabis |
| Change from baseline in cannabis use frequency following monitored abstinence (categorical) | Baseline and weekly in the 4 weeks immediately following discharge from residential withdrawal | Change from baseline in average frequency of cannabis use in the 4 weeks immediately following discharge from residential withdrawal, assessed weekly using the Timeline Follow-Back and categorized as follows: heavy use (5-7 days per week), moderate use (3-5 days) or light use (0-1 days) |
| Cannabis exposure | Approximately weekly between Baseline (week 0) and the end of treatment visit (week C7), approximately 12 weeks from baseline | The number of urine toxicology tests that are positive for cannabis exposure |
| Sleep quality (objective) during residential withdrawal admission | Daily during residential treatment for 4 to 14 days | Measured with wrist actigraphy |
| Cannabis withdrawal symptoms during residential withdrawal admission | Daily during residential treatment for 4 to 14 days | Measured with the Cannabis Withdrawal Scale |
| Sleep quality (subjective) during residential withdrawal admission | Daily during residential treatment for 4 to 14 days | Measured with the PROMIS Sleep Disturbance Scale |
| Change from baseline in daily functioning - social and occupational | Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal) | Measured with the Social and Occupational Functioning Assessment scale (SOFAS) |
| Change from baseline in daily functioning - multidimensional | Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal) | Measured with the Multidimensional Adolescent Functioning Scale (MAFS) |
| Change from baseline in daily functioning - social inclusion | Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal) | Measured with the Filia Social Inclusion Measure - 16 item scale (FSIM-16). |
| Change from baseline in cannabis use disorder symptoms | Baseline and end of Maintenance phase (4 weeks post discharge from residential withdrawal) | Change from baseline in number of cannabis use disorder symptoms endorsed at end of treatment as indexed by the Structured Clinical Interview for DSM-5 (SCID-5) |
Countries
Australia
Contacts
Primary ContactGillinder Bedi, DPsych
Backup ContactEmily A Karanges, PhD
Outcome results
None listed