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Dedicated to protecting and improving the health and environment of the people of Colorado

To:

Members of the State Board of Health

From:

Dr. Larry Wolk, Executive Director and Scientific Advisory Council Chair

Date:

December 17, 2014

Subject:

Request for approval of funding recommendations for Medical Marijuana Research Grant Program

The Medical Marijuana Research Grant Program was authorized by Senate Bill 14-155 “to fund research intended to ascertain the general medical efficacy and appropriate administration of marijuana and its component parts.” Senate Bill 14-155 also authorized the establishment of the Scientific Advisory Council (SAC) to “evaluate research proposals and submit recommendations to the department and the State Board of Health for recommended grant recipients, grant amounts, and grant duration.” The total amount of funding appropriated for research grants from the medical marijuana program cash fund is $9,000,000. A request for applications (RFA) was released September 3, 2014 and grants were due October 14. A total of 57 grants were received, of which 10 were disqualified for not meeting the timeliness or completeness requirements of the RFA. The 47 eligible grants were assigned for primary review by members of the SAC (excluding the chair and the patient representative) and six ad hoc reviewers. Each grant had three primary reviewers. A cut point was applied to the ordered list of primary review average scores, which identified 14 grants for further consideration by the full SAC. In addition, two of six grants from the next highest tier of average scores were nominated for further consideration by the full SAC. Thus, a total of 16 grants were discussed and re-scored by the full SAC on November 21. Based on the full SAC scores and further discussion regarding alignment with the intent of Senate Bill 14-155 and the RFA, eight grants were selected by the full SAC to be recommended to the Board of Health for funding approval. A table listing the proposed grant recipients, project titles, durations, primary investigators, and funding amounts requested is attached. One page abstracts of the eight grants are also attached. Of the eight grants, two will study the effectiveness of medical marijuana for Post Traumatic Stress Disorder (PTSD), two will study refractory pediatric epilepsy, and one each will study inflammatory bowel disease in adolescents and young adults, Parkinson’s Disease tremors, chronic spine pain, and palliative care for pediatric brain tumors. Seven of the eight grants are for 3 years duration, whereas, one grant is for 2 years. The SAC requests approval of the eight grants in an amount not to exceed $8,396,692. This amount encompasses the grant amount sought by the applicant and a 10 percent contingency per grantee (see attached table). The contingency enables the department to adjust each grant amount up to an additional 10 percent to allow grantees to address unforeseen costs identified during the contract negotiation process. If the funding for any grantee needs to be increased in an amount exceeding 10 percent of the grant amount, the SAC will request approval of the Board. The SAC anticipates that 7-15% ($600,000 and $1.36M) of the $9,000,000 of grant funding may remain available after contract negotiations. The SAC requests direction from the State Board of Health to either: 1) continue to review the applications for additional suitable grantees, or 2) develop and release a more specific RFA to fill an unmet gap or need, once the contracting phase for the currently recommended grantees is completed.

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Medical Marijuana Scientific Advisory Council Medical marijuana research grant recommendations Applicant

Project title (duration)

Primary investigator

University of Colorado Denver Anschutz Medical Campus

Do Adolescents and Young Adults with Inflammatory Bowel Disease Benefit from Use of Marijuana? (3 years)

Edward J. Hoffenberg, University of Colorado Denver School of Medicine, Children’s Hospital Colorado

University of Colorado Denver Anschutz Medical Campus

A Randomized, Double-blind, Placebo-controlled Crossover Study of Tolerability and Efficacy of Cannabidiol (CBD) on Tremor in Parkinson's Disease (3 years)

Maureen A. Leehey, Department of Neurology, University of Colorado

University of Pennsylvania School of Medicine

Treating PTSD with Marijuana: Clinical and Functional Outcomes (3 years)

Marcel O. Bonn-Miller, Dept. of Psychiatry, University of Pennsylvania, and VA National Center for PTSD

University of Colorado Denver Anschutz Medical Campus

Cannabidiol (CBD) and Pediatric Epilepsy (3 years)

University of Colorado Denver Anschutz Medical Campus

Medical Marijuana in the Pediatric Brain Tumor Population [palliative care] (3 years)

University of Colorado Denver Anschutz Medical Campus Multidisciplinary Association for Psychedelic Studies University of Colorado Denver Anschutz Medical Campus

Use of Medicinal Cannabinoids as Adjunctive Treatment for Medically Refractory Epilepsy [pediatric] (3 years)

George Sam Wang, Department of Pediatrics, University of Colorado and Children’s Hospital Colorado Nicholas Foreman, Dept. of Pediatrics, Pediatric Neuro-oncology, Children’s Hospital Colorado

Grant amount

(“up to” amount) $1,191,329 (1,310,462) $831,801 (914,981) $1,100,040 (1,210,044) $523,955 (576,350) $1,041,256 (1,145,382)

Kelly Knupp, Dept. of Pediatrics, Children’s Hospital Colorado and University of Colorado School of Medicine

$472,577.00

Placebo-controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Four Potencies of Smoked Marijuana in 76 Veterans with Chronic, Treatment- Resistant Post Traumatic Stress Disorder (3 years)

Marcel O. Bonn-Miller, University of Pennsylvania and VA National Center for PTSD

$2,000,000

A Double Blind, Placebo-Controlled Cross Study Comparing the Analgesic Efficacy of Cannabis versus Oxycodone (2 years)

Emily Lindley, Dept. of Orthopedics, University of Colorado

TOTAL

(519,835)

(2,200,000)

$472,398 (519,638)

$7,633,356 (8,396,692)

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Dedicated to protecting and improving the health and environment of the people of Colorado

The following Executive Summary is from the the application entitled: Do Adolescencents and Young Adults with Inflammatory Bowel Disease Benefit from Use of Marijuana?

4300 Cherry Creek Drive S., Denver, CO 80246-1530 P 303-692-2000 www.colorado.gov/cdphe John W. Hickenlooper, Governor | Larry Wolk, MD, MSPH, Executive Director and Chief Medical Officer

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Dedicated to protecting and improving the health and environment of the people of Colorado

The following Executive Summary is from the the application entitled: Placebo Controlled, Triple-blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Four Potencies of Smoked Marijuana in 76 Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

4300 Cherry Creek Drive S., Denver, CO 80246-1530 P 303-692-2000 www.colorado.gov/cdphe John W. Hickenlooper, Governor | Larry Wolk, MD, MSPH, Executive Director and Chief Medical Officer

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