NCT04605744

Brief Summary

This single arm study will assess whether smoking cessation counseling offered to chronic pain patients is effective in reducing pain and cigarette use.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
terminated

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 18, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2021

Completed
Last Updated

January 26, 2022

Status Verified

November 1, 2021

Enrollment Period

1.8 years

First QC Date

October 22, 2020

Last Update Submit

January 11, 2022

Conditions

Chronic PainSmoking

Outcome Measures

Primary Outcomes (1)

  • Pain

    Visual analogue pain score

    6 months

Interventions

Smoking cessation counselingBEHAVIORAL

Patients will be given a briefing on the benefits of smoking cessation in the peri-procedural period around their interventional pain procedure. They will also be provided an informational sheet from the American Society of Anesthesiologists promoting cessation. The sheet will contain the 1-800-QUITNOW national hotline phone number. Additional an enrollment folder will provided that contains referral information to Cooper's Tobacco Cessation program. This service, free of charge to Cooper Health patients consists of 5 tobacco cessation counselors who use personalized cessation plans, individual and group counseling cessations, Chantix, and education to promote smoking cessation.

Eligibility Criteria

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

You may qualify if:

  • Chronic Pain of 3 months or greater
  • Scheduled for interventional pain procedure

You may not qualify if:

  • Cancer related pain
  • Current participation in smoking abstinence program
  • History of schizophrenia or other pyschotic disorder
  • History of dementing illness
  • Pregnant patients
  • Diagnosis of depression or anxiety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Chronic PainSmoking

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 28, 2020

Study Start

February 18, 2020

Primary Completion

December 6, 2021

Study Completion

December 6, 2021

Last Updated

January 26, 2022

Record last verified: 2021-11

Locations

US(1)