The Development of of A Novel Therapeutic to Aid Tobacco Smoking Cessation in Persons With Schizophrenia or Schizoaffective Disorder (TRENDS)

NCT02230384 Phase 2 COMPLETED Results posted

The investigators will evaluate effects of a novel drug that improves nicotinergic receptor function vs. placebo on short-term smoking abstinence in smokers with schizophrenia who have a high interest in quitting. The investigators predict that the novel drug will increase days of abstinence, compared with placebo, identifying potential evidence of efficacy for smoking cessation in smokers with schizophrenia. The investigators will also assess if this new drug decreases nicotine withdrawal, craving, and cognitive impairment during early abstinence, as well as evaluate adverse effects.

Details

Lead sponsor	K.N. Roy Chengappa
Phase	Phase 2
Status	COMPLETED
Enrolment	62
Start date	2014-09
Completion	2017-03-09

Conditions

• Smoking Cessation

Interventions

• Active JNJ Drug
• Placebo Pill

Primary outcomes

• Quit Status — Daily - Mon-Fri during the quit week in each phase
  Complete abstinence from smoking for 24 hr, assessed daily from Mon-Fri for just one week. This same Mon-Fri procedure for one week (only) is done for both drug phases (Number of days abstinent per each quit week) Numbers reported are collapsed across medication conditions for each medication order.

Countries

United States