NCT03996902

Brief Summary

The goal of this study is to develop and pilot test a brief intervention to increase motivation to quit and smoking cessation treatment engagement among smokers with chronic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable chronic-pain

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

May 10, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

June 17, 2019

Last Update Submit

June 21, 2019

Conditions

Chronic PainSmokingSmoking Cessation

Keywords

Chronic PainTobaccoSmokingSmoking cessationMotivation

Outcome Measures

Primary Outcomes (3)

  • Motivation to Quit Smoking

    Measured by the Contemplation Ladder and Motivation Rulers. The contemplation ladder is a measure of motivation to quit smoking on an 11 point Visual Analogue Scale. Motivation rulers for smoking cessation consist of three separate NRSs that asses importance of quitting, readiness to quit smoking in the next month, and confidence that "you will quit smoking" in the next month.

    30 days

  • Motivation to engage cessation treatment

    Assessed with a single item that asked "would you like to learn about options for treatment to help you quit smoking. If participants answered yes they were then asked whether they were interested and planned to enroll in the following types of treatment in the next 30 days: medication/primary care, Quitline, behavioral health, or none of the above.

    30 days

  • Knowledge of pain-smoking interrelations

    Using the Pain and Smoking Questionnaire (PSQ) which is a 25 total item questionnaire to asses knowledge of interrelations between pain and tobacco smoking. 17 items assess knowledge of associations between smoking and multiple health conditions. 8 Separate items assess specific knowledge of pain-smoking interrelations such as pain related impairment, whether smoking can cause chronic pain, reduce effectiveness of prescription pain medications, provide analgesic effects, or help to distract from pain.

    30 days

Secondary Outcomes (2)

  • Smoking behavior

    30 days

  • Use of cessation treatment

    30 days

Study Arms (2)

Tailored intervention

EXPERIMENTAL

Brief Motivational Smoking Intervention

Behavioral: Tailored intervention

Control

EXPERIMENTAL

Intervention consistent with standard clinical practice (Control)

Behavioral: Ask-Advise-Refer

Interventions

Tailored interventionBEHAVIORAL

Brief motivational smoking intervention tailored to address smoking in the context of pain. Included a novel pain-smoking psycho education component, personalized feedback component, and elicitation of participant's pain-related goals to develop discrepancy between continued smoking and desired pain outcomes.

Tailored intervention
Ask-Advise-ReferBEHAVIORAL

The Ask-Advise-Refer intervention is commonly used in standard clinical practice.

Control

Eligibility Criteria

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

You may qualify if:

  • Current daily cigarette smoking (at least 10/day)
  • Current moderate-very sever chronic pain with a numerical pain rating of at least 4/10
  • At least 18 years of age

You may not qualify if:

  • Current active attempt to quit smoking
  • Enrollment in smoking cessation treatment or use of a smoking cessation medication
  • Less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joseph Ditre

Syracuse, New York, 13210, United States

Location

Related Publications (1)

  • Zale EL, Maisto SA, De Vita MJ, Hooten WM, Ditre JW. Increasing cessation motivation and treatment engagement among smokers in pain: A pilot randomized controlled trial. Exp Clin Psychopharmacol. 2021 Dec;29(6):593-604. doi: 10.1037/pha0000424. Epub 2020 Aug 6.

    PMID: 32757595DERIVED

MeSH Terms

Conditions

Chronic PainSmokingSmoking Cessation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorHealth Behavior

Study Officials

  • Emily Zale, PhD

    Syracuse University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2019

First Posted

June 25, 2019

Study Start

May 10, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data with other researchers.

Locations

US(1)