Condition category
Mental and Behavioural Disorders
Date applied
08/02/2006
Date assigned
24/02/2006
Last edited
18/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mike Franklin

ORCID ID

Contact details

BMS
Oxford Brookes University
Oxford
OX3 OBP
United Kingdom
michael.franklin@psych.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BMS2/05

Study information

Scientific title

Acronym

SJW

Study hypothesis

Our hypothesis is that St John's wort (SJW) will help people to stop smoking through its effects on dopamine, acetylcholine nicotinic receptors and serotonin to reduce the symptoms that occur following quitting and that chromium will reduce weight gain following quitting through its effects on insulin sensitivity.

Ethics approval

Approved by the local NHS Oxfordshire Ethics Committee

Study design

2 x 2 phase II randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Smoking cessation

Intervention

Patients are randomised to receive one of the following interventions:
1. SJW and chromium
2. Chromium and placebo
3. SJW and placebo
4. Control: placebo and placebo

Intervention type

Drug

Phase

Phase II

Drug names

St John's wort

Primary outcome measures

For SJW, primary outcome will be quitting at four weeks post quit, the standard for the NHS. For chromium, primary outcome will be weight change as defined by week 4 minus week 0 weight.

Secondary outcome measures

Relating to SJW, secondary outcomes include:
1. Side-effects of SJW withdrawal symptoms
2. Changes in State Trait Anxiety Inventory (STAI)
3. Questionnaire of Smoking Urges (QSU) brief
4. Mood and Physical Symptoms Scale (MPSS) questionnaires
5. Changes in salivary cortisol profile, plasma prolactin and free tryptophan


For chromium, secondary outcomes include:
1. Changes in food frequency questionnaire
2. Metabolic changes that might follow from changes in carbohydrate and lipid metabolism as a result of chromium. These are free tryptophan, Non-Esterified Free Fatty Acids (NEFFAs), Large Neutral Amino Acids (LNAAs), triglycerides and change in body fat estimated through bioimpedance.

Overall trial start date

21/02/2006

Overall trial end date

31/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Smokers 18 or over that want to stop smoking in the next two weeks and that have smoked at least 10 cigarettes per day for the past year and are clinically suitable to take SJW and chromium.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

144

Participant exclusion criteria

1. Pregnant women and breast-feeding women, or women who plan a pregnancy while on medication
2. Severe liver impairment
3. Current depression or moderate to severe depression within last six months
4. People with a past history of eating disorders
5. People with a past history of psychotic disorder
6. People with a history of alcohol or illegal drug use within the past six months
7. People taking medication that may interact with SJW

Recruitment start date

21/02/2006

Recruitment end date

31/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

BMS
Oxford
OX3 OBP
United Kingdom

Sponsor information

Organisation

Oxford Brookes University (UK)

Sponsor details

Gipsy Lane
Headington
Oxford
OX3 OBP
United Kingdom
jfrancis@brookes.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19328636

Publication citations

  1. Results

    Parsons A, Ingram J, Inglis J, Aveyard P, Johnstone E, Brown K, Franklin M, Bermudez I, A proof of concept randomised placebo controlled factorial trial to examine the efficacy of St John's wort for smoking cessation and chromium to prevent weight gain on smoking cessation., Drug Alcohol Depend, 2009, 102, 1-3, 116-122, doi: 10.1016/j.drugalcdep.2009.02.006.

Additional files

Editorial Notes