Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions

NCT02432066 | Withdrawn Phase 2 FDA Drug

• 3 other identifiers: IRB201500393Nixon2015R21DA038286
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Attempts to quit cigarette smoking are often accompanied by negative mood and problems in attention and memory. These effects, in turn, may contribute to smoking relapse. This exploratory/developmental project examines the effects of a novel medication, GTS-21, on individuals interested in smoking cessation. It is hypothesized that GTS-21 will reduce negative affect, improve cognition and/or reduce smoking relapse in healthy adult men and women who are chronic cigarette smokers.

Conditions

Tobacco Use Disorder

Keywords

Smoking; Smoking Cessation

Outcome Measures

Primary Outcomes (3)

• Change in Reported Nicotine Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8

  Nicotine use will be assessed using Timeline Followback procedures. Nicotine use will be reported to a trained interviewer using a Timeline Followback calendar, facilitated by calendars distributed to participants.

  Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8

• Change in Carbon Monoxide (CO) from baseline at weeks 5, 8

  Expired Carbon Monoxide levels will be quantified in parts per million.

  Change in baseline at Week 5, Week 8

• Change in Urine Cotinine (COT) from baseline at weeks 5, 8

  Cotinine excreted in urine will be quantified in ng/mL

  Change in baseline at Week 5, Week 8

Secondary Outcomes (63)

• Change in Beck Depression Inventory - II (BDI-II) from baseline at weeks 5, 8

  Change in baseline at Week 5, Week 8

• Change in State Anxiety Inventory (AI) from baseline at weeks 5, 8

  Change in baseline at Week 5, Week 8

• Change in State Anger (ANG-S) from baseline at weeks 5, 8

  Change in baseline at Week 5, Week 8

• Pill Count - Week 1

  Week 1

• Pill Count - Week 5

  Week 5

Study Arms (2)

GTS-21

ACTIVE COMPARATOR

Participants in the GTS-21 arm will receive 150 mg/BID GTS-21 over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.

Drug: GTS-21

Placebo

PLACEBO COMPARATOR

Participants in the Placebo arm will receive placebo compound twice daily over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.

Drug: Placebo

Interventions

GTS-21 DRUG

GTS-21 is a partial alpha7 nicotinic agonist. GTS-21 will be compounded by the UF investigational pharmacy, and administered orally.

Also known as: 3-(2,4-dimethoxybenzylidene) anabaseine (DMXB-A)

GTS-21

Placebo DRUG

Oral placebo pills, compounded by the UF investigational pharmacy

Also known as: Placebo Comparator

Placebo

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Minimum of 12 years of education
• Must report typical daily smoking of \> 10 cigarettes/day over the previous year
• Must report a history of at least 3 years of regular smoking
• Must provide carbon monoxide measures of at least 6.5 ppm
• Must report a willingness to quit smoking

You may not qualify if:

• Participants engaged in behavioral and/or nicotine replacement therapies, or assisted quit efforts, within previous 6 months.
• Must not meet criteria for other substance dependence or major psychiatric disorders.
• Must be absent chronic medical conditions that might jeopardize health and safety, confound data interpretation or that contraindicate the administration of compounds acting at nAChR sites. This list includes disorders with direct effects on neurologic function (e.g., seizure disorders, transient ischemic events, chronic or active hepatic disease), metabolic disorders (e.g., uncontrolled Type 2 diabetes), or cardiovascular disease (e.g., hypertension, mitral valve compromise, tachycardia, or irregular heart rates).
• Must not smoke only cigars, pipes or hookahs or use nicotine products but not cigarettes
• Must not report current use of nicotine replacement therapies (i.e., occasions of \> 4 h/week during a typical week, even if not used as a cessation aid)
• Must not have used bupropion within the previous year
• Must not report any past use (regardless of year) of varenicline
• Women may not be breastfeeding, pregnant or intending to become pregnant during the study period

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Smoking Cessation

Interventions

3-(2,4-dimethoxybenzylidene)anabaseine; anabaseine

Condition Hierarchy (Ancestors)

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

Study Officials

• Sara J Nixon, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 1, 2015
• Study Start: September 29, 2018
• Primary Completion: December 29, 2018
• Study Completion: December 29, 2020
• Last Updated: March 25, 2019

Record last verified: 2019-03