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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02085616
Other study ID # SRL00-367
Secondary ID
Status Terminated
Phase N/A
First received March 10, 2014
Last updated March 10, 2014
Start date February 2009
Est. completion date October 2011

Study information

Verified date March 2014
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study was to compare the effectiveness of the high-intensity proactive service with the low-intensity reactive service at the Swedish National Tobacco Quitline (SNTQ). Our hypothesis was that the effectiveness is about 5% higher in proactive than in reactive service.

The structured treatment protocol is a mixture of motivational interviewing (MI), cognitive behavior therapy, and pharmacological consultation.The standard process at the SNTQ is to offer the client a choice of callback (proactive service) or no callback (reactive service). In the present study clients were not offered a choice, but were randomized to proactive service on even dates and to reactive service on odd dates. Data are collected through postal questionnaires, one baseline and one follow-up after 12 months.


Recruitment information / eligibility

Status Terminated
Enrollment 586
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Tobacco users calling the SNTQ to discuss his/her own tobacco behaviour.

- The client gives verbal consent to sign up for cessation support.

- The client return a registration form including a baseline questionnaire

Exclusion Criteria:

- Snuff cessation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Proactive service
In the proactive service the callers to the quitline are offered a number of callbacks.
Reactive service
In the reactive service the callers to the quitline are informed that they can themselves call back whenever they like.

Locations

Country Name City State
Sweden Karolinska Institutet Stockholm
Sweden Stockholm County Council Stockholm
Sweden Centre for Clinical Research Västerås

Sponsors (8)

Lead Sponsor Collaborator
Uppsala University Karolinska Institutet, Stockholm County Council, Sweden, Swedish Cancer Society, Swedish Council for Working Life and Social Research, Swedish Heart Lung Foundation, The Swedish Research Council, Västmanland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Point prevalence abstinence Not a puff in the last week 12 months No
Secondary 6-month continuous abstinence Not a puff in the last 6 months 12 months No
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