NCT00500877

Brief Summary

Information obtained from this study will help us to have a better idea of how phone counseling may facilitate the process of quitting smoking for individuals with a history of recurrent depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

July 11, 2007

Last Update Submit

July 19, 2016

Conditions

Cigarette Smoking

Keywords

Smoking cessationPhone Counseling

Outcome Measures

Primary Outcomes (1)

  • Smoking Abstinence

    6 months

Study Arms (2)

Mood Management Phone counseling

ACTIVE COMPARATOR

Mood management phone counseling for smoking cessation

Behavioral: Mood Management Phone Counseling for Smoking Cessation

Phone Counseling Standard

PLACEBO COMPARATOR

Phone counseling standard

Behavioral: Mood Management Phone Counseling for Smoking Cessation

Interventions

Mood Management Phone Counseling for Smoking CessationBEHAVIORAL

Phone counseling addressed mood management and smoking cessation

Mood Management Phone counselingPhone Counseling Standard

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • history of two or more past episodes of depression
  • regular cigarette smoker for at least one year
  • currently smoking 10 or more cigarettes each day
  • want to quit smoking

You may not qualify if:

  • Current Depressive Episode
  • Current Alcohol of Substance abuse
  • Pregnant, planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Cigarette SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseHealth Behavior

Study Officials

  • David Strong, Ph.D.

    Butler Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 13, 2007

Study Start

February 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations

US(1)