Biological correlates of self-reported new and continued abstinence in cannabis cessation treatment clinical trials

Abstract

Background: The agreement between self-reported cannabis abstinence with urine cannabinoid concentrations in a clinical trials setting is not well characterized. We assessed the agreement between various cannabinoid cutoffs and self-reported abstinence across three clinical trials, one including contingency management for abstinence.

Methods: Three cannabis cessation clinical trials where participants reported use and provided weekly urine samples for cannabis and creatinine concentration measurements were included. Bootstrapped data were assessed for agreement between self-reported 7+ day abstinence and urine cannabinoid tests using generalized linear mixed effects models for clustered binary outcomes. One study implemented contingency management for cannabis abstinence. Four hundred and seventy-three participants with 3787 valid urine specimens were included. Urine was analyzed for 11-nor-9-carboxy-Δ9-tetrahydrocannabinol and creatinine using immunoassay methods Biological cutoffs of 50, 100, and 200 ng/ml, as well as changes in CN normalized THCCOOH (25%/50% decrease), were assessed for agreement with self-reported abstinence during the three clinical trials.

Results: Agreement between measured THCCOOH and self-reported abstinence increases with increasing cutoff concentrations, while the agreement with self-reported non-abstinence decreases with increasing cutoff concentrations. Combining THCCOOH cutoffs with recent changes in CN-THCCOOH provides a better agreement in those self-reporting abstinence. Participants in the studies that received CM for abstinence had a lower agreement between self-reported abstinence and returned to use than those in studies that did not have a contingency management component.

Conclusion: Using combinations of biological measurements and self-reported abstinence, confirmation of study related abstinence may be verifiable earlier and with greater accuracy than relying on a single measurement.

Keywords: Cannabis; Clinical trials; Concentrations; Contingency management; Self-Report; Urine cannabinoid.

Figure 1

Figure 1a. New abstinence. Figure 1b. Return to use. Note: Agreement between UCT data and A) self-reported new abstinence and B) self-reported return to use from prior abstinence between Static UCT cutoff values and a combination of Static cutoff values and recent changes in CN-THCCOOH. Data are shown as the mean bootstrapped percentage agreement between UCT and self-reported measures and the associated 95% confidence interval. * p<0.05

Figure 2

Figure 2a. New abstinence, with contingency management. Figure 2b. Return to use, with contingency management. Note: Agreement between UCT data and A) self-reported new abstinence and B) self-reported return to use from prior abstinence between those whom did and did not receive contingnecy management for abstinence (CM). Data are shown as the mean bootstrapped percentage agreement between UCT and self-reported measures and the associated 95% confidence interval. * p<0.05.