NCT03262233

Stress Neuroadaptation in Tobacco Dependence

Completed Phase 4 Results posted Last updated 23 April 2019

What this trial tests

Phase 4 trial testing nicotine in Nicotine Dependence in 226 participants. Completed in 20 February 2018.

Timeline

1 April 2015

Primary endpoint
20 February 2018

20 February 2018

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	226
Start date	1 April 2015
Primary completion	20 February 2018
Estimated completion	20 February 2018
Sites	1 location across United States

Drugs / interventions tested

• nicotine (NICOTINE) — full drug profile →
• placebo

Conditions studied

• Nicotine Dependence — all drugs for Nicotine Dependence →

Sponsor

University of Wisconsin, Madison

Who can join

Adults 18 to 60, any sex, with Nicotine Dependence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Stressor Reactivity Primary · up to 24 hours after start of cessation attempt (deprived groups); during normal smoking prior to quit attempt, ie. Baseline (non-deprived groups)

The average of unpredictable startle potentiation and predictable startle potentiation during the first administration of the NPU stressor task.

Group	Value	95% CI
Active Deprived	25.1	± 23.0
Active Non-deprived	22.5	± 24.4
Placebo Deprived	32.3	± 29.6
Placebo Non-deprived	16.9	± 17.7

Relative Unpredictable Stressor Reactivity Primary · up to 24 hours post cessation attempt (deprived groups); during normal smoking prior to quit attempt, ie. Baseline (non-deprived groups)

Unpredictable startle potentiation minus predictable startle potentiation during the first administration of the NPU stressor task

Group	Value	95% CI
Active Deprived	-6.77	± 14.0
Active Non-Deprived	-7.91	± 14.4
Placebo Deprived	-6.06	± 12.3
Placebo Non-deprived	-4.99	± 14.0

Change in Overall Stressor Reactivity Primary · baseline and up to 14 days post cessation attempt (non-deprived groups); baseline and up to 24 hours post quit attempt (deprived groups)

A difference score of overall stressor reactivity during the second administration of the NPU stressor task relative to the first NPU stressor task

Group	Value	95% CI
Active Deprived	-2.94	± 16.3
Active Non-Deprived	0.929	± 13.0
Placebo Deprived	-10.3	± 24.0
Placebo Non-deprived	4.78	± 13.6

Change in Relative Unpredictable Stressor Reactivity Primary · baseline and up to 14 days post cessation attempt (non-deprived groups); baseline and up to 24 hours post quit attempt (deprived groups)

A difference score of relative unpredictable stressor reactivity during the second administration of the NPU stressor task relative to the first NPU stressor task

Group	Value	95% CI
Active Deprived	1.95	± 15.5
Active Non-Deprived	3.99	± 14.8
Placebo Deprived	0.889	± 16.0
Placebo Non-deprived	-1.35	± 11.3

Sponsor's own description

The objective of the current study is to evaluate the validity of the No Shock, Predictable Shock, Unpredictable Shock (NPU) stressor task for use as a surrogate endpoint to predict short-term clinical outcomes among smokers during a smoking cessation attempt.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.