Dataset Information

Progesterone for smoking relapse prevention following delivery: A pilot, randomized, double-blind study.

ABSTRACT: INTRODUCTION:Close to half of women who were smokers prior to conception quit smoking in pregnancy, when endogenous progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop. The current pilot study tested the feasibility and preliminary efficacy of postpartum progesterone replacement in preventing relapse to smoking in postpartum women with a history of pre-pregnancy smoking. METHODS:This was an 8-week, double-blind, parallel, randomized, placebo-controlled pilot trial of 41 women with a history of pre-pregnancy smoking who achieved abstinence by 32 weeks of gestation. Immediately following delivery women were randomized to oral micronized progesterone (200mg twice daily) or placebo via computerized urn randomization program. The main outcome measures were descriptions of study feasibility: recruitment and retention. Secondary outcomes were 7-day point prevalence of abstinence at week 8, time to relapse and smoking cravings. RESULTS:The trial was feasible with adequate randomization, 64% (41/64) of eligible women, and trial retention, 78% (32/41) completed the trial. Women taking progesterone were 1.8 times more likely to be abstinent during week 8 and took longer to relapse (10 vs. 4 weeks) compared to the placebo group, although these differences did not reach statistical significance. After adjusting for age and pre-quit smoking level, the number needed to treat was 7. There was a 10% greater decline per week in craving ratings in the progesterone group compared to placebo (?=-0.10, 95% CI: -0.15, -0.04, p<0.01). No serious adverse events occurred during the trial. CONCLUSIONS:These preliminary findings support the promise of progesterone treatment in postpartum smokers and could constitute a therapeutic breakthrough.If these preliminary findings can be evaluated and replicated in a larger study with sufficient power, this may constitute an acceptable and safe smoking relapse prevention strategy for use during lactation.

SUBMITTER: Forray A

PROVIDER: S-EPMC5659923 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Progesterone for smoking relapse prevention following delivery: A pilot, randomized, double-blind study.

Forray Ariadna A Gilstad-Hayden Kathryn K Suppies Cristine C Bogen Debra D Sofuoglu Mehmet M Yonkers Kimberly A KA

Psychoneuroendocrinology 20170914

<h4>Introduction</h4>Close to half of women who were smokers prior to conception quit smoking in pregnancy, when endogenous progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop. The current pilot study tested the feasibility and preliminary efficacy of postpartum progesterone replacement in preventing relapse to smoking in postpartum women with a history of pre-pregnancy smoking.<h4>Methods</h4>This ...[more]

PMID: 28926762

Similar Datasets

Project description:Abstract Background: Relapse is common in schizophrenia; identifying characteristics associated with relapse may help improve disease management. Cariprazine, a D3/D2 receptor partial agonist, is approved in the United States for the treatment of schizophrenia. Post hoc analyses of a long-term, randomized, double-blind (up to 72 weeks), relapse prevention trial (NCT01412060) were performed to identify characteristics associated with relapse in placebo- and cariprazine-treated patients. Methods: Baseline characteristics in cariprazine-treated (3, 6, or 9?mg/d) or placebo-treated patients were evaluated in relation to relapse status. Demographic variables included age, sex, race, weight, and BMI. Psychiatric history variables included mean age at illness onset, duration of schizophrenia, duration of current episode, number of lifetime psychotic episodes, previous hospitalizations, and acute exacerbations in the past year. Baseline rating scale severity scores (eg, Positive and Negative Syndrome Scale [PANSS] and Clinical Global Impressions-Severity [CGI-S]) were evaluated. Differences in demographic and psychiatric history variables were evaluated using the Student t test (categorical variables) or Fisher exact test (continuous variables); rating scale severity scores were evaluated with 2-way ANOVA with relapse and study center as factors. Results: Relapse occurred in nearly twice as many placebo-treated (47.5%) as cariprazine-treated patients (24.8%) (hazard ratio [95% CI] = 0.45 [0.28, 0.73]). For cariprazine-treated patients who relapsed vs those who did not, significant differences were seen in baseline age (mean, 43 vs 38 y), weight (85 vs 73?kg), BMI (29 vs 26?kg/m2), and race (all, P < .05); for placebo-treated patients, there were no significant differences in demographic variables based on relapse status. In both treatment groups, patients who relapsed vs patients who did not relapse had a greater mean number of previous hospitalizations (cariprazine = 8.4 vs 4.3 [P = .0199]; placebo = 4.9 vs 2.8 [P = .0183]). Cariprazine patients who relapsed vs those who did not had longer illness duration (18.1 y vs 9.9 [P = .0005]); the number of lifetime episodes also differed by relapse status (P = .0016), with a greater percentage of relapsed patients experiencing ?5 episodes. Baseline PANSS total score and CGI-S scores were not significantly different in relapsed vs nonrelapsed patients in either treatment group. Conclusion: While patients treated with cariprazine had a lower rate of relapse than placebo overall, the results suggest that patients who were older, heavier, or had a later stage of illness may be more prone to relapse during cariprazine treatment. In patients randomized to placebo, demographic characteristics and psychiatric history were not as meaningful in predicting relapse. Greater symptom severity at baseline did not appear to be associated with relapse.

Project description:BackgroundTo date, antidepressant drugs show limited efficacy, leaving a large number of patients experiencing severe and persistent symptoms of major depression. Previous open-label clinical trials have reported significant sustained improvements with deep brain stimulation (DBS) of the subcallosal cingulate gyrus (SCG) in patients with severe, chronic treatment-resistant depression (TRD). This study aimed to confirm the efficacy and measure the impact of discontinuation of the electrical stimulation.MethodsWe conducted a 6-month double-blind, randomized, sham-controlled crossover study in implanted patients with previous severe TRD who experienced full remission after chronic stimulation. After more than 3 months of stable remission, patients were randomly assigned to 2 treatment arms: the ON-OFF arm, which involved active electrode stimulation for 3 months followed by sham stimulation for 3 months, and the OFF-ON arm, which involved sham stimulation for 3 months followed by active stimulation for 3 months. The primary outcome measure was the difference in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score between sham and active stimulation.ResultsWe enrolled 5 patients in our trial. A Friedman repeated-measures analysis of variance revealed a significant effect of treatment (χ(2)1 = 5.0, p = 0.025) in patients with higher depression scores during sham stimulation. At the end of active stimulation, depression was remitted in 4 of 5 patients and none of them had experienced a relapse, whereas at the end of sham stimulation, 2 patients remained in remission, 2 relapsed and 1 showed a progressive worsening without reaching relapse criteria.LimitationsThe small sample size limited the statistical power and external validity.ConclusionThese preliminary findings indicate that DBS of the SCG is an effective and safe treatment for severe forms of TRD and that continuous electrical stimulation is required to maintain therapeutic effects.Trial registrationNCT01268137 (ClinicalTrials.gov).

Dataset Information

Progesterone for smoking relapse prevention following delivery: A pilot, randomized, double-blind study.

Publications

Progesterone for smoking relapse prevention following delivery: A pilot, randomized, double-blind study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets