None listed
Conditions
Brief summary
Nicotine addiction is a chronic condition caused by continued tobacco smoking to prevent unpleasant nicotine withdrawal symptoms that occur after smoking cessation. Smoking cessation has immediate as well as long-term health benefits. The two main components in the process of quitting are (i) making a quit attempt, and (ii) maintaining abstinence after that attempt. Smoking cessation interventions typically involve some counselling and pharmacotherapy. A national quit line service is provided by 53 countries giving information and counselling to smokers who want to quit. Quitline New Zealand reports a quit rate of 43% at four weeks, a rate comparable to that of other high-income countries, maintaining this abstinence long-term is crucial for the prevalence of smoking to decrease. A few (<10%) of the quit line services offer discounted Nicotine Replacement Therapy (NRT), the most common pharmacotherapy used for smoking cessation which includes nicotine gum, patches, and lozenges. Bupropion hydrochloride [Zyban Registered Trademark] doubles a person’s chance of quitting compared to placebo with quit rates similar to NRT reporting a four week quit rate of 30- 60%. Varenicline [Chantix/Champix Registered Trademark] is reported to have quit rates between 30-50%. Pharmacological therapies improve the chances of abstinent rates but they can be relatively complex to deliver, require prescription and supervision, and side effects can be problematic. Alternative treatments that are safe, effective, and readily available are needed. Nutritional interventions are one such alternative. Over the last decade, interest in the impact that nutrition on both health and psychological wellbeing in the treatment of mental illness has grown and micronutrients (vitamins and minerals) are being studied for the treatment of psychiatric conditions (Rucklidge & Kaplan, 2013). In the treatment of addictions, Blum and colleagues developed formulas called “neuronutrients” or “nueroadaptagens” that mainly consist of amino acids, minerals and vitamins (Blum, Allison, Trachtenberg, Williams, & Loeblich, 1988), nutrients to reduce relapse rates, drug hunger and withdrawal, and improve psychological functioning. One case study, using a single case reversal (off-on-off-on-off) design, showed on-off control of psychiatric symptoms as the micronutrients were consumed or withdrawn, but also simultaneous on-off use of cannabis and tobacco smoking (Harrison, Rucklidge, & Blampied, 2013). I have also conducted a pilot study examining the use of a micronutrient formula, Daily Essential Nutrients (DEN) in conjunction with standard Quitline New Zealand care, by individuals attempting to quit smoking (Newton, Blampied, Rucklidge, 2014 in preparation). The micronutrient intervention resulted in a significantly increased chance of being successful at a quit attempt and an increased rate of quitting at four, eight and 12-weeks compared to placebo, providing evidence that micronutrients improve quit success. My PhD will attempt to further support the role of micronutrients in addiction by conducting a randomised controlled trial study with a larger sample size and improved assessments. Participants will take micronutrients or placebo while trying to quit smoking
Interventions
Double blind randomized controlled trial (RCT) comparing a micronutrient (vitamins and minerals) supplement Daily Essential Nutrients (DEN) with a placebo during a smoking cessation intervention followed by an open-label phase. The intervention consists of standard Quitline New Zealand care combined with a micronutrient formula (DEN) containing 41 ingredients: The doses of each ingredient in one capsule are: Vitamin A (as retinyl palmitate) 384 IU
Vitamin C (as ascorbic acid) 40 mg
Vitamin D (a
Double blind randomized controlled trial (RCT) comparing a micronutrient (vitamins and minerals) supplement Daily Essential Nutrients (DEN) with a placebo during a smoking cessation intervention followed by an open-label phase. The intervention consists of standard Quitline New Zealand care combined with a micronutrient formula (DEN) containing 41 ingredients: The doses of each ingredient in one capsule are: Vitamin A (as retinyl palmitate) 384 IU Vitamin C (as ascorbic acid) 40 mg Vitamin D (as cholecalciferol) 200 IU Vitamin E (as d-alpha tocopheryl succinate) 24 IU Vitamin K (as phylloquinone) 6 mcg Vitamin K (as menaquinone-7) 2 mcg Thiamin (as thiamin mononitrate) 4 mg Riboflavin 1.2 mg Niacin (as niacinamide) 6 mg Vitamin B6 (as pyridoxine hydrochloride) 4.6667 mg Folate (as folic acid) 50 mcg Folate (as L-methylfolate calcium) 50 mcg Vitamin B12 (as methylcobalamin) 60 mcg Biotin 72 mcg Pantothenic acid (as d-calcium pantothenate) 2 mg Calcium (as chelate) 88 mg Iron (as chelate) 0.916 mg Phosphorus (as chelate) 56 mg Iodine (as chelate) 13.6 mcg Magnesium (as chelate) 40 mg Zinc (as chelate) 3.2 mg Selenium (as chelate) 13.6 mcg Copper (as chelate) 0.48 mg Manganese (as chelate) 0.64 mg Chromium (as chelate) 41.6 mcg Molybdenum (as chelate) 9.6 mcg Potassium (as chelate) 16 mg Choline bitartrate 36 mg Alpha-lipoic acid 33.333 mg Shilajit 12.5 mg Inositol 12 mg Acetylcarnitine (as acetyl-L-carnitine hydrochloride) 4 mg Grape seed extract 3 mg Ginkgo biloba leaf extract 2.4 mg Methionine (as L-methionine hydrochloride) 2 mgCysteine (as N-acetyl-L-cysteine) 2 mg Germanium sesquioxide (as chelate) 1.38 mg Boron (as chelate) 0.16 mg Vanadium (as chelate) 0.0796 mg Lithium orotate (as chelate) 0.0667 mg Nickel (as chelate) 0.002 mg Other ingredients: Cellulose 49.122 mg Glycine 45 mg Citric acid 26.814 mg Magnesium stearate 24 mg Silicon dioxide 20 mg Baseline phase: Participants will be recruited via advertising to complete an online questionnaire that will assess their eligibility for the study and collect their demographic information. Eligible participants will be invited to the laboratory for their first consultation. At this consultation information will be given to the participant about the study and if they agree to take part they will sign a consent form. Participants will then complete baseline questionnaires; Smoking history, FTND, mCEQ, AUTOS, TCQ-12, AUDIT-C, Self-efficacy, MNWS, WSWS, DASS-21, ASI, DEMF and side effects. Participant’s weight and blood pressure will also be measured at this consultation. During the two week baseline participants will complete a daily diary of MPSS withdrawal symptoms and the number of cigarettes consumed. After the two weeks (end of baseline) the participants will come back in to the laboratory and complete the questionnaires again, excluding the smoking history questionnaire. Pre-quitting (second baseline) phase (4 weeks): Once baseline phase is completed participants will come in to the laboratory for a second time and receive a four weeks supply of capsules (randomized to placebo (n=40) or micronutrients (n=40)) in plain containers. On days 1-2 participants will take 1 capsule 3 times daily, day 3-4 2 capsules 3 times daily, 5-6 3 capsules 3 times daily. On day 7 they will have titrated up to their full dose of 12 capsules/day and will continue to take three doses of four capsules with food and plenty of water each day for the remainder of the trial. For the first and the last weeks of the pre-quitting phase participants will complete a daily diary of recordings identical to baseline. Participants will complete the same questionnaires as baseline at two and four weeks of this phase. This phase permits the assessment of micronutrient consumption on smoking and related symptoms and on psychological health and wellbeing prior to any quit attempt being made. Smoking cessation phase (12 weeks): After four weeks of taking the capsules participants will begin a smoking cessation intervention following Quitline New Zealand's five-step program (with the exclusion of step 4 that involves Nicotine Replacement Therapy) and continue to consume the capsules for 12 weeks. This smoking cessation phase will begin on an agreed quit date. Participants will monitor withdrawal symptoms (MPSS) for the first month after their quit date, then again in weeks eight and 12 using the daily diary. Every two weeks participants will also receive an email to complete questionnaires. Every 4 weeks participants will come in to the laboratory to complete questionnaires, receive more capsules and measure breath carbon monoxide to confirm smoking abstinence. Smoking relapse will be monitored, and participants are instructed to contact the researcher if they inhale a cigarette and to record it in the diary. Any participant that recorded smoking for 3 days in a row is counted as having a relapse. Participants that relapse continue to consume capsules and the researcher will help them to set a new quit date. If a participant is not smoke free at week 8 of this phase they will be asked to start the open-label phase (4-weeks earlier). Open-label phase (4 weeks): At the end of smoking cessation phase participants will come in to the laboratory. All participants (smoking/non-smoking) will be offered a four-week open label phase where they will all be placed on the micronutrient capsules (12/day). During this phase they will complete a daily diary. Participants who are still smoking will be contacted prior to this visit to make the start of this phase a new quit date for them to re-attempt to quit smoking. Two-weeks in to this phase participants will receive an email to complete questionnaires. At the end of this phase participants will come back in to the laboratory for the last time, complete questionnaires and discuss any smoking cessation techniques Quitline suggests for long-term abstinence. Participants will be followed up 2 months after this phase by completing online questionnaires and report any smoking.
Sponsors
University of Canterbury
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) 18 years old or over 2) meet a 'current smoking' criteria of smoking at least three cigarettes a day for the past year 3) no serious medical conditions that require treatment during trial period 4) are not on psychoactive medication. Participants must be medication free for at least four weeks prior to beginning the trial.
Exclusion criteria
1) under 18 years old 2) not a 'current smoker' of three or more cigarettes a day for the past year 3) on any psychoactive medication 4) any serious medical condition
Outcome results
None listed