N/A
Completed N=16
Fixed or Self-Titrated Dosages of Sativex on Cannabis Users
Cannabis Dependence
Source: ClinicalTrials.gov NCT01748799 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Feasibility — 1; 1; 1; 2 participants
Summary
The purpose of this study is to to demonstrate the feasibility and tolerability of the use of Sativex in cannabis dependent individuals and to assess the effects of fixed or self titrated dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a buccal spray) on withdrawal symptoms, craving scores and cannabis consumption during the study period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility |
1; 1; 1; 2; 1; 1 | — |
| SECONDARY Tolerability of Sativex in Persons That Are Cannabis Dependent |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Cannabis Withdrawal |
10.3; 7.9; 9.8; 6.6; 17.9; 8.6 | <0.01 sig |
Eligibility Criteria
Inclusion Criteria
- age 18-50
- current cannabis dependence
- cannabis as primary drug of abuse
- frequent cannabis use (i.e., at least 5 days per week)
- have experienced at least 2 withdrawal symptoms during previous cessation periods
- cannabis use not for medical purposes (i.e., not a government-licensed medical cannabis user)
- not seeking treatment for cannabis dependence
- willingness to participate in study protocol
Exclusion Criteria
- meet criteria for any psychiatric disorder requiring psychiatric intervention
- have a history of seizures; c)have known sensitivity to Dronabinol, Cannabidiol, Propylene glycole, Ethanol or peppermint oil (used in Sativex buccal spray
- suffer from an unstable medical condition
- currently have physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
- currently taking psychotropic medication with benefit for any other illness than treatment of insomnia
- pregnant or breast-feeding
- hold a job that involves operating heavy machinery
- currently seeking treatment for cannabis-related problems
- family history of psychotic symptoms
Data sourced from ClinicalTrials.gov (NCT01748799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.