NCT03015597

Brief Summary

The purpose of this study is to see whether contingency management (CM) can be successfully added as an adjunct treatment to standard stop smoking services in outpatients undergoing treatment for opiate addiction. Forty tobacco smoking patients undergoing treatment for opiate addiction will be stratified to a CM intervention for either smoking abstinence or attendance at the clinic, whilst also receiving usual stop smoking services cessation treatment. The intervention will run for five weeks and participants will be followed up six months after the beginning of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

November 29, 2017

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

September 28, 2016

Last Update Submit

November 27, 2017

Conditions

Keywords

SmokingTobacco SmokingSmoking, TobaccoSmoking CessationOpiate AddictionOpiate DependenceContingency Management

Outcome Measures

Primary Outcomes (1)

  • Number of participants completing treatment in each condition

    Number of participants completing treatment in each condition

    6 weeks

Secondary Outcomes (3)

  • Percentage of negative samples

    Each week throughout intervention (weeks 1-6) and at 6 month follow up

  • Longest duration of abstinence

    Each week throughout intervention (weeks 1-6) and at 6 month follow up

  • Point Prevalence abstinence

    Each week throughout intervention (weeks 1-6) and at 6 month follow up

Study Arms (2)

Contingency Management: smoking

EXPERIMENTAL

Contingency Management: smoking Participants receive rewards contingent on biochemical verification of tobacco smoking abstinence

Behavioral: Contingency Management

Contingency Management: attendance

PLACEBO COMPARATOR

Contingency Management: attendance Participants receive rewards contingent on attending the stop smoking clinic (independent of smoking status)

Behavioral: Contingency Management

Interventions

Contingency management is a behavioural intervention based on the principals of operant conditioning that is widely used in the addictions field. At the most basic level, contingency management works by providing rewards as reinforcement for desired behaviours. In the current study, the desired behaviours are either attendance at the clinic and abstinence from tobacco smoking, or just attendance at the clinic, dependent on the arm of the trial that participants are randomised to. Participants in the experimental condition will receive shopping vouchers for attending the clinic and providing a breath CO recording of \<10ppm. Participants in the control condition will receive shopping vouchers for attending the clinic, regardless of their breath CO recording results.

Contingency Management: attendanceContingency Management: smoking

Eligibility Criteria

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

You may qualify if:

  • Want to quit smoking
  • Between 18 and 65 years old
  • Undergoing current pharmacological treatment for opiate addiction
  • Smoke a minimum of 10 cigarettes per day
  • Provide informed consent.

You may not qualify if:

  • Insufficient English skills to understand study protocols
  • Currently undergoing treatment for drugs other that opiates or tobacco
  • Taking part in other research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lorraine Hewitt Hosue

London, United Kingdom

Location

Related Publications (1)

  • Ainscough TS, Brose LS, Strang J, McNeill A. Contingency management for tobacco smoking during opioid addiction treatment: Implementation challenges. Drug Alcohol Rev. 2021 May;40(4):658-661. doi: 10.1111/dar.13216. Epub 2020 Nov 24.

MeSH Terms

Conditions

SmokingTobacco SmokingSmoking CessationOpioid-Related Disorders

Condition Hierarchy (Ancestors)

BehaviorTobacco UseHealth BehaviorNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Ann McNeill, PhD

    King's College London

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2016

First Posted

January 10, 2017

Study Start

October 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

November 29, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Permission is not being sought for this from participants to expedite recruitment

Locations