Trial Outcomes & Findings for Treatment of Nicotine Dependence and Acute Depression (NCT NCT00186446)

NCT ID: NCT00186446

Last Updated: 2017-04-04

Results Overview

Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher values indicate more depression. % Change in depression score from baseline to week 10. Negative values indicate a reduction in depression.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: baseline to week 10
• Results posted on: 2017-04-04

Participant Flow

Participant milestones

Measure	Bupropion and Smoking Cessation Behavioral Intervention Medication for depression and behavioral intervention for smoking cessation
Overall Study STARTED	20
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Nicotine Dependence and Acute Depression

Baseline characteristics by cohort

Measure	Bupropion and Smoking Cessation Behavioral Intervention n=20 Participants
Age, Continuous	44.35 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to week 10

Population: 9 patients did not complete the study and we used last observation carried forward

Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher values indicate more depression. % Change in depression score from baseline to week 10. Negative values indicate a reduction in depression.

Outcome measures

Measure	Bupropion and Smoking Cessation Behavioral Intervention n=20 Participants
Hamilton Depression Scale Score	-.5322 percentage of change in depression Standard Deviation .27

PRIMARY outcome

Timeframe: Week 10

Population: Carbon monoxide levels available on 8 subjects at week 10.

Carbon monoxide breath level of below 9PPM which indicates cessation of smoking.

Outcome measures

Measure	Bupropion and Smoking Cessation Behavioral Intervention n=8 Participants
Cessation of Smoking	7 Participants

PRIMARY outcome

Timeframe: Dropouts over course of study

Population: Number dropped out of the study

This was measured by the drop out rate during the study.

Outcome measures

Measure	Bupropion and Smoking Cessation Behavioral Intervention n=20 Participants
Can Depression and Smoking Cessation be Treated Simultaneously	9 Participants

Adverse Events

Bupropion and Smoking Cessation Behavioral Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

aimee-noelle swanson

Stanford University

Phone: 650-736-4559

Email: aimnoe@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place