Preventing Tobacco Relapse With Omega-3s Trial

NCT03113370 | Withdrawn

• 1 other identifier: 162131
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Almost 12% of women report smoking during pregnancy. Smoking during pregnancy is associated with adverse fetal outcomes and up to 35-75% of women quit smoking during their pregnancy. Clinical trials of tobacco cessation medications have reported safety concerns along with limited efficacy. Subsequently, these medications are not generally recommended in pregnancy and most women who stop smoking do so unassisted. Not surprisingly, the rates of smoking relapse in the post-partum period are up to 67%. To date, clinical trials of behavior interventions in the post-partum period have been largely null. Pharmacotherapy has not been studied as a means of preventing relapse in smokers who quit without the use of medications. Additionally, these medications are excreted in breast milk, which limits there use for lactating women. Thus alternative, safe, and effective strategies to prevent smoking relapse in high-risk, former smokers during the post-partum period are needed. n-3 long-chain polyunsaturated fatty acids (LCPUFA) have anti-inflammatory properties and appear effective as adjuvant therapy for depression. In animal models, n-3 LCPUFA deficiencies can result in hypofunctioning of the dopamine mesocorticolimbic pathways which are related to reward and dependence. Nicotine results in an elevation of dopamine in the nucleus accumbens which is associated with the pleasurable sensations related to nicotine use. It has been hypothesized that correcting the hypofunctioning dopaminergic system through n-3 LCPUFA supplementation might reduce nicotine cravings. Taken together, these studies suggest that supplemental n-3 LCPUFA might be useful in preventing smoking relapse. The investigators' hypothesis is that post-partum former smokers randomized to n-3 LCPUFA supplementation will be less likely to relapse and have less nicotine cravings compared to women allocated to placebo. To test this hypothesis they will conduct a 12-week, randomized, double-blind, placebo controlled study of 4 grams/day n-3 LCPUFA supplementation versus placebo. Participants will be enrolled prior to hospital discharge. The primary outcomes of the trial will be time to smoking relapse and change in self-reported nicotine cravings. The secondary outcome will be point prevalence abstinence at 6- and 12-weeks. compliance will be monitored by measuring red blood cell phospholipid fatty acid content and verify smoking cessation through end-expired CO and cotinine.

Conditions

Tobacco Dependence

Keywords

n-3 polyunsaturated fatty acids; tobacco use; postpartum

Outcome Measures

Primary Outcomes (1)

• Time to smoking relapse

  Time to smoking relapse

  3-months

Secondary Outcomes (1)

• Point prevalence abstinence

  3-months

Study Arms (2)

Fish Oil

EXPERIMENTAL

4 grams of fish oil per day

Dietary Supplement: Fish Oil

Placebo

PLACEBO COMPARATOR

4 grams of olive oil capsules per day

Dietary Supplement: Placebo

Interventions

Fish Oil DIETARY_SUPPLEMENT

Fish Oil capsules

Fish Oil

Placebo DIETARY_SUPPLEMENT

Olive Oil

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Post-partum women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≥ 18 years of age
• Reported smoking 5 or more cigarettes per day prior to pregnancy
• Currently no longer smoking
• Immediately post-partum (within 24 hours of an uncomplicated delivery)
• Delivery of a health infant (no low birth weight, term delivery)

You may not qualify if:

• Allergy to fish or seafood
• Actively using fish oil supplements and unwilling to stop for the trial duration
• Unstable psychiatric disease
• Complicated delivery or unstable infant
• Unstable medical problems
• Current alcohol or illicit drug use

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo controlled
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel arm randomized, double-blind, placebo controlled trial

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: December 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share