NCT03786224

Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence

Completed NA Results posted Last updated 2 August 2024

What this trial tests

NA trial testing Contingency Management in Cannabis Use in 6 participants. Completed in 6 December 2019.

Timeline

1 July 2019

Primary endpoint
6 December 2019

6 December 2019

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	6
Start date	1 July 2019
Primary completion	6 December 2019
Estimated completion	6 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Contingency Management

Conditions studied

• Cannabis Use — all drugs for Cannabis Use →
• Adolescent Behavior — all drugs for Adolescent Behavior →

Sponsor

Massachusetts General Hospital

Who can join

Adults 13 to 19, any sex, with Cannabis Use or Adolescent Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Continuous Abstinence Via Progressive Declines in Urine THCCOOH Primary · Six months

Cannabis abstinence will be indexed by progressively decreasing quantitative levels (ng/mL) of 11-nor-delta-9-THC-9-carboxylic acid (THCCOOH), the primary cannabis metabolite, in urine. Residual cannabinoid excretion will be differentiated from new cannabis exposure using a statistical model developed by Schwilke and colleagues (2011). This model was empirically derived from urine CN-THCCOOH concentration ratios of consecutively collected specimen pairs (current specimen/prior specimen). This model takes into account the time between collection of specimens, which enhances the accuracy of pred

Group	Value	95% CI
Abstinent	NA	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected over 6 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Abstinent

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (11 terms — click to expand)

Reaction	System	Abstinent
Common Cold	Infections and infestations	—
Difficulty Sleeping	General disorders	—
Loss of Appetitie	Metabolism and nutrition disorders	—
Indigestion	Gastrointestinal disorders	—
Increased Stress	Social circumstances	—
Skin Wound	Injury, poisoning and procedural complications	—
Worsening Depression	Psychiatric disorders	—
Worsening Suicidal Ideation	Psychiatric disorders	—
Soreness	Musculoskeletal and connective tissue disorders	—
Increased Irritability	Psychiatric disorders	—
Hot flashes	General disorders	—

Data from ClinicalTrials.gov NCT03786224 adverse events section.

Sponsor's own description

This study is a critically important first-of-its-kind investigation of the potential research utility of using contingency management to examine long-term changes in cannabis use with six months of abstinence. These pilot data will inform a later trial which will focus on testing the longitudinal relationships between adolescent cognition and cannabis use, questions of high and growing public health significance given adolescents' increased access to cannabis with legalization.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.