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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01037088
Other study ID # 200614658
Secondary ID C06-DA-119
Status Completed
Phase Phase 1/Phase 2
First received December 17, 2009
Last updated January 11, 2018
Start date December 2009
Est. completion date November 2012

Study information

Verified date October 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.


Description:

We conducted a double-blind, placebo-controlled, crossover study evaluating the analgesic efficacy of vaporized cannabis in subjects, the majority of whom were experiencing neuropathic pain despite traditional treatment. Thirty-nine patients with central and peripheral neuropathic pain underwent a standardized procedure for inhaling medium-dose (3.53%), low-dose (1.29%), or placebo cannabis with the primary outcome being visual analog scale pain intensity. Psychoactive side effects and neuropsychological performance were also evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Age greater than 18 and less than 70

- Visual Analogue Scale (VAS pain intensity) greater than 3/10

- A negative urine drug screening test, i.e., no evidence of IV drug abuse

- Neuropathic pain due to reflex sympathetic dystrophy, peripheral neuropathy, post-herpetic neuralgia, post-stroke pain, multiple sclerosis or spinal cord injury

Exclusion Criteria:

- Presence of another painful condition of greater severity than the neuropathic pain condition which is being studied.

- Subjects with moderate-severe major depression, bipolar/mania, bipolar II/hypomania and schizophrenia or schizoaffective disorder.

- Unstable Type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl

- History of traumatic brain injury

- Uncontrolled medical condition, including coronary artery disease, hypertension, cerebrovascular disease, asthma, tuberculosis (TB), chronic obstructive pulmonary disease (COPD), opportunistic infection, malignancy requiring active treatment, active substance abuse (alcohol or injection drugs).

- Current use of marijuana (e.g., within 30 days of randomization)

- Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test.

Study Design


Intervention

Drug:
Mild dose cannabis
3.53% THC by weight
Low dose cannabis
1.29% THC by weight
Cannabis
0.00% THC by weight

Locations

Country Name City State
United States CTSC Clinical Research Center, Sacramento VA Medical Center Sacramento California

Sponsors (3)

Lead Sponsor Collaborator
University of California, Davis Center for Medicinal Cannabis Research, VA Northern California Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain. 2008 Jun;9(6):506-21. doi: 10.1016/j.jpain.2007.12.010. Epub 2008 Apr 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Participants With 30% or Greater Reduction in Pain Intensity The primary outcome variable, VAS Pain Intensity, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).An assessment was performed before the administration of vaporized cannabis or placebo and hourly thereafter for six hours. baseline to six hours
Secondary Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis The pain intensity scores for all of the time points (i.e., baseline prior to administration and up to 5 hours following administration of cannabis). VAS Pain Intensity was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain). baseline to six hours
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