Nicotinic Receptors and Schizophrenia
4 other identifiers
interventional
97
1 country
2
Brief Summary
The investigators hypothesize that sustained-release DMXB-A-SR (3-2,4 dimethoxybenzylidene anabaseine sustained release) will provide clinical improvement in cognition in patients with schizophrenia who are smokers and who are non-smokers. The study drug may also maintain abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 schizophrenia
Started Jul 2011
Longer than P75 for phase_2 schizophrenia
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 14, 2011
CompletedFirst Posted
Study publicly available on registry
July 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
May 7, 2019
CompletedMay 7, 2019
April 1, 2019
3.9 years
July 14, 2011
April 21, 2017
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurocognitive Efficacy
MATRICS CCB Neurocognitive T-score (Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery Statistically Adjusted-score). Higher scores indicate better neurocognitive functionality.
4 weeks
Secondary Outcomes (1)
Inhibition of Auditory Evoked Potential P50 to Repeated Stimuli
4 weeks
Study Arms (2)
DMXB-A-SR
EXPERIMENTALStudy Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR), 3-2, 4 dimethoxybenzylidene anabaseine sustained release (GTS-21)
Arm #2: Placebo Comparator
PLACEBO COMPARATORInert capsule to resemble active drug.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects will be selected to be 18 to 65 years old and in good general health.
- Subjects who fulfill Diagnostic and Statistical Manual -IV-Text Revision (DSM-IV-TR) criteria for schizophrenia or schizoaffective disorder.
- Smokers will smoke at least 20 cigarettes per day.
- Non-smokers will also be enrolled.
- Subjects will have normal:
- vital signs,
- hematology,
- serum chemistries,
- EKG, and
- urinalysis with a negative drug screen before entry into the study.
- Subjects will be fluent in English.
- Smoking subjects will be interested in stopping smoking in the near future and not interested in nicotine replacement therapy.
You may not qualify if:
- Subjects with histories of:
- neurological illness,
- liver disease,
- severe hypertension (cut-off blood pressure 160/100) or
- cardiac disease, or
- renal failure (cut-off creatinine above 1.4).
- Subjects who currently meet DSM-IV-TR criteria for substance dependence other than nicotine, cannabis, or alcohol will be excluded.
- Women who are capable of pregnancy and not on acceptable forms of birth control will be excluded.
- Subjects being treated with Clozapine will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UColorado Denver
Aurora, Colorado, 80045, United States
University of Colorado-Anschutz Medical Campus, Department of Psychiatry
Aurora, Colorado, 80045, United States
Related Publications (3)
Olincy A, Harris JG, Johnson LL, Pender V, Kongs S, Allensworth D, Ellis J, Zerbe GO, Leonard S, Stevens KE, Stevens JO, Martin L, Adler LE, Soti F, Kem WR, Freedman R. Proof-of-concept trial of an alpha7 nicotinic agonist in schizophrenia. Arch Gen Psychiatry. 2006 Jun;63(6):630-8. doi: 10.1001/archpsyc.63.6.630.
PMID: 16754836BACKGROUNDFreedman R, Olincy A, Buchanan RW, Harris JG, Gold JM, Johnson L, Allensworth D, Guzman-Bonilla A, Clement B, Ball MP, Kutnick J, Pender V, Martin LF, Stevens KE, Wagner BD, Zerbe GO, Soti F, Kem WR. Initial phase 2 trial of a nicotinic agonist in schizophrenia. Am J Psychiatry. 2008 Aug;165(8):1040-7. doi: 10.1176/appi.ajp.2008.07071135. Epub 2008 Apr 1.
PMID: 18381905BACKGROUNDKem WR, Olincy A, Johnson L, Harris J, Wagner BD, Buchanan RW, Christians U, Freedman R. Pharmacokinetic Limitations on Effects of an Alpha7-Nicotinic Receptor Agonist in Schizophrenia: Randomized Trial with an Extended-Release Formulation. Neuropsychopharmacology. 2018 Feb;43(3):583-589. doi: 10.1038/npp.2017.182. Epub 2017 Aug 21.
PMID: 28825423DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert Freedman
- Organization
- University of Colorado
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Freedman, MD
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The pharmacist places the treatment or placebo into identical coded vials. Only the pharmacist and the statistician have the code to identify of the treatment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2011
First Posted
July 22, 2011
Study Start
July 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 7, 2019
Results First Posted
May 7, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share
Individual patient description can be obtained from Robert.Freedman@ucdenver.edu. It will be available December 1, 2017.