A randomized controlled trial of daily aerobic exercise for inpatient cannabis withdrawal

Not Applicable

• Conditions: Cannabis Withdrawal; Mental Health - Addiction

• Registration Number: ACTRN12615000211561
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

(a) At least 18 years of age,

(b)meets ICD-10 criteria for cannabis dependence,

(c)reports significant cannabis withdrawal symptoms in previous periods of abstinence,

(d)capacity to tolerate moderate exercise, and

(e) willing and capable of providing informed consent to the study procedures.

Exclusion Criteria

(a) Alcohol dependence (and associated alcohol withdrawal sequel by clinical assessment);

(b) Regular use of other drugs (excluding caffeine, alcohol, and tobacco) or injecting drug use more than once per week on average in previous 28 days;

(c) Any Drug and Alcohol treatment in the last 28 days;

(d) Significant medical conditions impacting upon exercise capacity, metabolism and excretion of cannabinoids, or assessment of cognition and performance (including severe cardiovascular, neurological, hepatic, renal, respiratory and endocrine disorders; or haematological conditions:

(e) Active and severe psychiatric disorders that warrant immediate psychiatric treatment (outside of experimental trial conditions), impact upon capacity for consent, or assessment of outcomes, such as psychosis, suicidality, delirium and severe affective disorders (mild or moderate levels of depression or anxiety not excluded);

(f) Use of medications that may impact upon the metabolism and excretion of cannabinoids (e.g. CYP450 enyzme inducers/inhibitors), or may impact upon measurement of withdrawal features (e.g. mood stabilisers, sedatives); and

(g)Pregnancy (plasma hCG screen in women of child bearing potential).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates of completion of the 7 day inpatient detoxification regime[Day of discharge from the 7 day inpatient stay];Daily measures of cannabis withdrawal severity using the Cannabis Withdrawal Scale [Daily during the 7 day inpatient detox];Daily measures of cannabis cravings using the Marijuana Cravings Questionnaire[Daily during the 7 day inpatient detox]

Secondary Outcome Measures

Name	Time	Method
Plasma measures of THC, THC-COOH, 11-OH-THC, CBD, lipolysis, anandamide, 2-AG, and BDNF pre- and post-exercise [Days 1, 3 and 7];Daily urinary cannabinoid levels[Daily during the 7 day inpatient detox];Pre-post exercise measures of cognitive function and psychomotor performance using computerised cognitive performance measures (RAVLT, Erickson flankers task,Stop-Signal Task, Rapid Visual Information Processing, Digit symbol substitution)[Days 1, 3 and 7];Any adverse events during the 7 day admission such as an unexpected reaction to exercise regime [Daily during the 7 day inpatient detox];Mood (DASS-21)[28 day follow-up];Self-reported measures of drug use (days used Timeline Followback)[28-day follow up];psychosocial functioning (SF-12)[28 day follow up];Patient ratings of global improvement [Day 7 of inpatient stay]