NCT04271371

Brief Summary

Prisoners experience huge health inequalities, and their exceptionally high smoking prevalence (five times the national average) contributes significantly to their high mortality. Since the introduction of smoke-free polices across Her Majesty's Prison and Probation Service (HMPPS) in England and Wales, prisoners are now obliged to abstain from smoking while held in prison. This represents a unique opportunity to promote lifelong cessation in this highly disadvantaged and marginalised group. However, evidence suggests most prisoners intend to resume smoking as soon as possible after release. A systematic review of prison smoke-free polices worldwide concluded that there was a need for new research to identify effective strategies to reduce relapse in these individuals.

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 all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

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

August 8, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3.7 years

First QC Date

September 6, 2019

Last Update Submit

February 26, 2024

Conditions

Keywords

SmokingSmoking ReductionElectronic Cigarette UsePrison

Outcome Measures

Primary Outcomes (1)

  • To develop and pilot test the feasibility and acceptability of an intervention to help prevent prisoners relapse to smoking after release.

    Smoking abstinence rates at 1 week, 1 month and 3 months post release, self-reported.

    3 years

Secondary Outcomes (18)

  • To document prisoners smoking history to date and levels of nicotine addiction.

    1 year

  • To document the support provided to manage nicotine addiction during imprisonment and in the periods immediately before and after release.

    1 year

  • The impact of smoke-free prison policy on prisoners smoking behaviours.

    1 year

  • To establish the extent to which prisoners intentionally resume or unintentionally relapse to smoking after release (and does their intended behaviour pre-release predict post-release behaviour).

    1 year

  • To establish the extent to which prisoners relapse to smoking after transfer to an open prison where smoking is permitted in designated areas.

    1 year

  • +13 more secondary outcomes

Study Arms (1)

Prototype intervention

To be developed through Phase 1 and 2

Other: Not yet developed

Interventions

A prototype intervention will be developed over Phase 1 \& 2 and piloted in Phase 3 of this study.

Prototype intervention

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsParticipants recruited from male prison establishments only
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male prisoner population

You may qualify if:

  • All participants are aged 18 or over (no upper age limit)
  • Are currently residing in one of the three study sites (HMPs Nottingham, Ranby and Sudbury)
  • Male (women will not be held at any of the study sites)
  • Have a provisional release date within the next 2 months.
  • Are capable of understanding and consenting to the study.
  • Remand and sentenced prisoners.
  • Who report that they are a current smoker and/or a current smoker prior to entering prison (smoked up to 7 days before entering prison), and/or were in prison (and still on the same sentence) and a current smoker prior to the smoke-free prison policy.
  • \. Reception prisoner cross-sectional
  • All participants are aged 18 or over (no upper age limit)
  • Are currently residing in the open prison study site (HMP Sudbury)
  • Male (women will not be held at any of the study sites)
  • Have been in the open prison more than two weeks but for less than 3 months.
  • Have been transferred from a closed prison.
  • Are capable of understanding and consenting to the study.
  • Sentenced prisoners.
  • +1 more criteria

You may not qualify if:

  • Present a serious risk of harm to the researchers, highlighted in PNOMIS records or by a member of staff.
  • Non-smokers.
  • Being deported post release.
  • Been in prison for less than four weeks.
  • \. Reception prisoner cross-sectional
  • Present a serious risk of harm to the researchers, highlighted in PNOMIS records or by a member of staff.
  • Been in prison for less than 2 weeks.
  • Non-smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham, School of Medicine

Nottingham, Please Select, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

SmokingSmoking ReductionVaping

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2019

First Posted

February 17, 2020

Study Start

August 8, 2019

Primary Completion

May 1, 2023

Study Completion

December 30, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations