NCT01740960: THC

Safety and Tolerability of Oral Namisol®, a Tablet Containing Delta-9-Tetrahydrocannabinol, in Elderly Subjects: A Randomized Controlled Trial

Completed Phase 1 Last updated 6 January 2014

What this trial tests

Phase 1 trial testing delta-9-tetrahydrocannabinol in Drug Safety in 12 participants. Completed in 1 December 2012.

Timeline

1 August 2012

Primary endpoint
1 December 2012

1 December 2012

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	12
Start date	1 August 2012
Primary completion	1 December 2012
Estimated completion	1 December 2012
Sites	1 location across Netherlands

Drugs / interventions tested

• delta-9-tetrahydrocannabinol — full drug profile →
• Placebo

Conditions studied

• Drug Safety — all drugs for Drug Safety →

Sponsor

Radboud University Medical Center

Who can join

65 and older, any sex, with Drug Safety. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• THC adverse effects checklist and self-reporting by the subjects
  Time frame: Pre dose, 0h30m, 1h30m and at 2h30m post ingestion
  Safety and tolerability of Namisol® will be evaluated by assessing the incidence and severity of adverse events on each intervention visit by using a standardized THC adverse effects checklist and self-reporting by the subjects.

Sponsor's own description

The results of phase I Namisol® study (Klumpers et al. Br J Clin Pharmacol, 2012), implicate that Namisol® may have a favorable PK and PD characteristics and is safe to use in people. However, the study included only young adults with a mean age of 21.4 years. In a previous THC study, subjects age has been associated with treatment response and tolerance of adverse reactions. This association was not supported by Lane et al. and Volicer et al.

There is concern about the safety and tolerability of THC in the elderly population. This is because, elderly persons in general have higher risk of adverse drug reactions due to a combination of physiological factors such as decreasing in lean body mass, the reduction of renal and hepatic clearance, and medical comorbidity which can lead to polypharmacy and drug-drug interactions. Therefore, data from the phase I trial cannot be translated directly to an elderly (and likely more vulnerable) population. This makes it important to evaluate the safety and tolerability profiles of different Namisol® doses in the elderly. In our study in progress "Delta-THC in Behavioral Disturbances in Dementia", the Namisol® doses of 0,75 mg and 1,5 mg are, until now, well tolerated by elderly subjects. These doses are, however, very low in comparison with the doses used in phase I study with young adults (5 mg, 6,5 mg and 8 mg). The current study on the safety and tolerability of relatively high doses of Namisol® will help us in the future to provide broad advice on the therapeutic index and safety profile of Namisol® in the elderly population.

Publications & conference data

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