GRACE: Guanfacine Extended-release for Adolescents With Cannabis Use
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Guanfacine extended-release Guanfacine extended-release (target dose 4 mg), once daily for approximately 12 weeks plus treatment as usual |
Drug: Guanfacine Extended Release Oral Tablet
Target dose 4 mg daily
Other Names:
Behavioral: Residential withdrawal
4-14 days in residential withdrawal treatment
Behavioral: Engagement 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
|
| Placebo Comparator: Placebo Placebo once daily for approximately 12 weeks plus treatment as usual |
Behavioral: Residential withdrawal
4-14 days in residential withdrawal treatment
Behavioral: Engagement 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
Drug: Placebo
Placebo capsule taken daily
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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)
- 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
- Cannabis craving during residential withdrawal admission [Daily during residential treatment for 4 to 14 days]
Measured with the Brief Substance Craving Scale - Cannabis
- Sleep quality (objective) during residential withdrawal admission [Daily during residential treatment for 4 to 14 days]
Measured with wrist actigraphy
- 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
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
12-25 years of age (inclusive) at consent;
-
Seeking treatment for cannabis use;
-
DSM-5 Cannabis Use Disorder, mild, moderate or severe;
-
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
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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:
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DSM-5 substance use disorder (moderate or severe) except cannabis or nicotine;
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Any unstable medical, psychiatric or neurological condition or medical contraindicating study participation;
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Diagnosis of a psychotic or bipolar illness;
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Acute suicidality as assessed by clinician;
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Severe depression (>15 on the Quick Inventory of Depression Symptomatology; QIDS);
-
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;
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A history of heart disease or cardiac risk factors (e.g. arrhythmias);
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Abnormal liver or thyroid function as indicated by clinically-significant findings on blood tests;
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Pregnancy, breast feeding or, if sexually active and able to become pregnant, no effective contraception.
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Intention to enter residential rehabilitation after treatment in the YSAS residential withdrawal facility.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orygen | Parkville | Victoria | Australia | 3052 |
Sponsors and Collaborators
- Orygen
- Youth Support and Advocacy Service
- University of Melbourne
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22389