Does Sativex (THC/CBD spray) have abuse potential? Evidence says low risk | Research

The takeaway

Across clinical trials, Sativex produced low intoxication scores, euphoria in only 2.2% of patients, no tolerance development, and no withdrawal syndrome upon stopping.

Read this if you want to know whether THC-based prescription medicines carry addiction risk.

Only 2.2% of Sativex patients reported euphoria

What the researchers found

This review compiled safety data from all published Sativex clinical trials, including the integrated safety analysis for multiple sclerosis patients. Intoxication scores were consistently low. Only 2.2% of patients reported euphoria.

Tolerance did not develop over extended use, meaning patients did not need increasing doses for the same effect. When patients stopped Sativex abruptly, no formal withdrawal syndrome occurred. No cases of abuse or diversion were reported.

A separate formal abuse liability study in recreational cannabis users showed Sativex had some abuse potential at higher doses compared to placebo, but scores were consistently lower than equivalent doses of pure THC (dronabinol).

Why it matters

Any THC-containing medicine raises concerns about abuse potential. This evidence suggested that the 1:1 THC:CBD formulation and oromucosal delivery route of Sativex produced substantially less abuse liability than pure THC or smoked cannabis.

The numbers in context

Euphoria reported by 2.2% of patients. No tolerance development. No withdrawal syndrome on abrupt cessation. Abuse liability scores consistently lower than equivalent THC doses.

How the study worked

Review of all published clinical trial data for Sativex, plus GW Pharmaceuticals' integrated safety database for MS patients. Also referenced a formal abuse liability study comparing Sativex to dronabinol in recreational cannabis users.

What this study cannot tell us

Review compiled by a single author associated with cannabis medicine research. Clinical trial populations (MS patients) may differ from recreational users in their responses. The formal abuse liability study used recreational users, which represents a high-risk population.

How to read the evidence

Review of clinical trial safety data. Comprehensive dataset but author was associated with the field of cannabis medicine.

When this study was published

Published in 2011. Sativex has accumulated more post-marketing safety data since this review.

The bigger picture

The low abuse potential of Sativex supported the idea that CBD may modulate the rewarding effects of THC. This had implications for how cannabinoid medicines are formulated and regulated.

Questions still open

Does CBD directly reduce THC's euphoric effects, or does the delivery route matter more? Would abuse potential change with long-term access? How do these findings apply to other THC:CBD combinations?

Common questions

Can you get high from Sativex?

In clinical trials, intoxication scores were low and only 2.2% of patients reported euphoria. The combination of THC with CBD and the slow oromucosal absorption route appears to reduce psychoactive effects compared to smoking cannabis.

Why does Sativex have less abuse potential than pure THC?

Two factors likely contribute: CBD may modulate THC's rewarding effects, and oromucosal spray delivers THC more slowly than smoking, reducing the rapid onset "rush" associated with abuse potential.

Read the original research

Abuse potential and psychoactive effects of δ-9-tetrahydrocannabinol and cannabidiol oromucosal spray (Sativex), a new cannabinoid medicine.

Expert opinion on drug safety, 10(5), 675-85

View on PubMed ↗Publisher’s paper ↗

Citation

Robson, Philip. (2011). Abuse potential and psychoactive effects of δ-9-tetrahydrocannabinol and cannabidiol oromucosal spray (Sativex), a new cannabinoid medicine.. Expert opinion on drug safety, 10(5), 675-85. https://doi.org/10.1517/14740338.2011.575778