An fMRI Study of SYN115 in Cocaine Dependent Subjects

NCT00783276 | Completed Early Phase 1 DMC

• 3 other identifiers: DA009262-14P50DA009262DPMCDA
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The dopamine system is critical in modulation of reward and has been implicated in the initiation and maintenance of addiction (Volkow et al 2004). Medications that increase dopamine either directly or indirectly have been shown to have preliminary efficacy at reducing cocaine use in cocaine dependent subjects (Grabowski et al 2004a; Schmitz et al 2008). A novel class of medications that has recently been shown to indirectly modulate dopamine function is adenosine A2A receptor antagonists (Fuxe et al 2007). Based on their effect on dopamine function it has been suggested that these compounds may be efficacious in the treatment of drug addiction (Ferre et al 2007c). Before clinical efficacy studies are undertaken, more basic research on the effects of adenosine A2A antagonists on brain function and behavior are warranted. The aim of this study is to examine the acute effects of a single dose of the selective adenosine A2A antagonist (SYN115, Synosia Therapeutics, Chemical name: 4-Hydroxy-4-methyl-piperidine-1-carboxylic acid-(4-methoxy-7-morpholin-4-yl-benzothiazol-2-yl)-amide) on brain function and behavior in cocaine dependent individuals using functional magnetic resonance imaging (fMRI). To examine the effect of a single dose of SYN115 on brain function and behavior in cocaine dependent subjects. Hypotheses:

1. 1.SYN115 100 mg will increase brain activation in the dorsolateral prefrontal cortex compared to placebo in cocaine dependent subjects performing a working memory task.
2. 2.SYN115 100 mg will increase brain activation in the ventral striatum compared to placebo in cocaine dependent subjects performing a reversal learning task.
3. 3.SYN115 100 mg will reduce brain activation in the anterior cingulate gyrus and amygdala compared to placebo in cocaine dependent subjects performing a cocaine-word Stroop task.

Conditions

Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• fMRI Brain Activation

  Minutes

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Placebo

Drug: PLACEBO

SYN115

ACTIVE COMPARATOR

Drug: SYN115

Interventions

SYN115 DRUG

100 mg single dose

SYN115

PLACEBO DRUG

PLACEBO

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Moeller FG, Steinberg JL, Lane SD, Kjome KL, Ma L, Ferre S, Schmitz JM, Green CE, Bandak SI, Renshaw PF, Kramer LA, Narayana PA. Increased Orbitofrontal Brain Activation after Administration of a Selective Adenosine A(2A) Antagonist in Cocaine Dependent Subjects. Front Psychiatry. 2012 May 28;3:44. doi: 10.3389/fpsyt.2012.00044. eCollection 2012.

  PMID: 22654774 RESULT

• Lane S, Green C, Steinberg J, Ma L, Schmitz J, Rathnayaka N, Bandak S, Ferre S, Moeller F. Cardiovascular and Subjective Effects of the Novel Adenosine A(2A) Receptor Antagonist SYN115 in Cocaine Dependent Individuals. J Addict Res Ther. 2012 Mar 28;S1:009. doi: 10.4172/2155-6105.S1-009.

  PMID: 22905331 RESULT

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

tozadenant

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Frederick G Moeller, M.D.

  UTHSC-Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 19, 2019

Record last verified: 2016-07

Locations

US (1)