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A randomized controlled trial of a manual-only treatment for reduction and cessation of problematic caffeine use.

ABSTRACT: BACKGROUND:Caffeine Use Disorder was added to DSM-5 as a diagnosis for further research, but few studies have been conducted to identify effective treatments. This randomized, controlled clinical trial examined the efficacy of a manual-only treatment program for caffeine cessation and reduction among individuals seeking treatment for problematic caffeine use. METHODS:Individuals meeting at least two proposed DSM-5 diagnostic criteria for Caffeine Use Disorder were randomly assigned to receive either immediate treatment or treatment delayed by 7 weeks. The treatment consisted of a manual containing information about caffeine and instructions for gradually reducing caffeine consumption over a period of 6 weeks, with no counseling or additional support. Caffeine consumption and caffeine-related distress were assessed before treatment, 7 weeks after receiving the treatment manual (end-of-treatment), and 20 weeks post-treatment. RESULTS:The manual-only treatment resulted in significant reductions in participants' self-reported caffeine consumption and caffeine-related distress at end-of-treatment that were sustained at 20-weeks post-treatment. Salivary caffeine levels and community observers corroborated the self-reported reductions in caffeine consumption. Comparisons between the immediate and delayed treatment groups suggest the reductions in caffeine consumption were attributable to the manualized treatment rather than spontaneous with the passage of time. CONCLUSIONS:The present study provides evidence that a gradual caffeine reduction and cessation program may be successfully implemented using a manual-only approach. This time- and cost-effective intervention may be easily adopted by practitioners with limited time or experience with behavioral interventions who want to encourage their patients to reduce caffeine consumption.

SUBMITTER: Sweeney MM

PROVIDER: S-EPMC6563338 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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A randomized controlled trial of a manual-only treatment for reduction and cessation of problematic caffeine use.

Sweeney Mary M MM Meredith Steven E SE Juliano Laura M LM Evatt Daniel P DP Griffiths Roland R RR

Drug and alcohol dependence 20181124

<h4>Background</h4>Caffeine Use Disorder was added to DSM-5 as a diagnosis for further research, but few studies have been conducted to identify effective treatments. This randomized, controlled clinical trial examined the efficacy of a manual-only treatment program for caffeine cessation and reduction among individuals seeking treatment for problematic caffeine use.<h4>Methods</h4>Individuals meeting at least two proposed DSM-5 diagnostic criteria for Caffeine Use Disorder were randomly assigne ...[more]

PMID: 30580203

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Project description:The Internet has increasingly been studied as mode of delivery for interventions targeting problematic alcohol use. Most interventions have been fully automated, but some research suggests that adding counselor guidance may improve alcohol consumption outcomes.An eight-module Internet-based self-help program based on cognitive behavioral therapy (CBT) was tested among Internet help-seekers. Eighty participants with problematic alcohol use according to the Alcohol Use Disorders Identification Test (AUDIT; scores of ? 6 for women and ? 8 for men) were recruited online from an open access website and randomized into three different groups. All groups were offered the same self-help program, but participants in two of the three groups received Internet-based counselor guidance in addition to the self-help program. One of the guidance groups was given a choice between guidance via asynchronous text messages or synchronous text-based chat, while the other guidance group received counselor guidance via asynchronous text messages only.In the choice group, 65% (13 of 20 participants) chose guidance via asynchronous text messages. At the 10-week post-treatment follow-up, an intention-to-treat (ITT) analysis showed that participants in the two guidance groups (choice and messages) reported significantly lower past week alcohol consumption compared to the group without guidance; 10.8 (SD = 12.1) versus 22.6 (SD = 18.4); p = 0.001; Cohen's d = 0.77. Participants in both guidance groups reported significantly lower scores on the AUDIT at follow-up compared to the group without guidance, with a mean score of 14.4 (SD = 5.2) versus 18.2 (SD = 5.9); p = 0.003; Cohen's d = 0.68. A higher proportion of participants in the guidance groups said that they would recommend the program compared to the group without guidance (81% for choice; 93% for messages versus 47% for self-help).Self-help programs for problematic alcohol use can be more effective in reducing alcohol consumption over a 10-week period when counselor guidance is added.Clinicaltrials.gov NCT02384304.

Project description:ObjectiveEpidemiologic studies consistently link caffeine, a nonselective adenosine antagonist, to lower risk of Parkinson disease (PD). However, the symptomatic effects of caffeine in PD have not been adequately evaluated.MethodsWe conducted a 6-week randomized controlled trial of caffeine in PD to assess effects upon daytime somnolence, motor severity, and other nonmotor features. Patients with PD with daytime somnolence (Epworth >10) were given caffeine 100 mg twice daily ×3 weeks, then 200 mg twice daily ×3 weeks, or matching placebo. The primary outcome was the Epworth Sleepiness Scale score. Secondary outcomes included motor severity, sleep markers, fatigue, depression, and quality of life. Effects of caffeine were analyzed with Bayesian hierarchical models, adjusting for study site, baseline scores, age, and sex.ResultsOf 61 patients, 31 were randomized to placebo and 30 to caffeine. On the primary intention-to-treat analysis, caffeine resulted in a nonsignificant reduction in Epworth Sleepiness Scale score (-1.71 points; 95% confidence interval [CI] -3.57, 0.13). However, somnolence improved on the Clinical Global Impression of Change (+0.64; 0.16, 1.13, intention-to-treat), with significant reduction in Epworth Sleepiness Scale score on per-protocol analysis (-1.97; -3.87, -0.05). Caffeine reduced the total Unified Parkinson's Disease Rating Scale score (-4.69 points; -7.7, -1.6) and the objective motor component (-3.15 points; -5.50, -0.83). Other than modest improvement in global health measures, there were no changes in quality of life, depression, or sleep quality. Adverse events were comparable in caffeine and placebo groups.ConclusionsCaffeine provided only equivocal borderline improvement in excessive somnolence in PD, but improved objective motor measures. These potential motor benefits suggest that a larger long-term trial of caffeine is warranted.Classification of evidenceThis study provides Class I evidence that caffeine, up to 200 mg BID for 6 weeks, had no significant benefit on excessive daytime sleepiness in patients with PD.

Project description:Epidemiological studies suggest that smokeless tobacco in the form of Swedish snus has been used by many smokers in Scandinavia to quit smoking, but the efficacy of snus has so far not been evaluated in controlled clinical trials.We conducted a randomized, double-blind, placebo-controlled, clinical trial aimed at assessing the efficacy of snus to help adult cigarette smokers in Serbia to substantially reduce, and, eventually, completely stop smoking. The study enrolled 319 healthy smokers aged 20-65 years at two occupational health centers in Belgrade, Serbia. Most of them (81%) expressed an interest to quit rather than just reduce their smoking. Study products were used ad libitum throughout the 48-week study period. The main study objective during the first 24 weeks was smoking reduction. The primary end-point was defined as a biologically verified reduction of ? 50% in the average number of smoked cigarettes per day during week 21-24 compared to baseline. During week 25-48 participants were actively instructed to stop smoking completely. Outcome measures of biologically verified, complete smoking cessation included 1-week point prevalence rates at clinical visits after 12, 24, 36, and 48 weeks, as well as 4-, 12- and 24-week continued cessation rates at the week 36 and 48 visits.At the week 24 visit, the proportion of participants who achieved the protocol definition of a ? 50% smoking reduction was similar in the two treatment groups. However, the proportion that reported more extreme reductions (? 75%) was statistically significantly higher in the snus group than in the placebo group (p < 0.01). The results for biologically verified complete cessation suggested that participants in the snus group were more likely to quit smoking completely than the controls; the odds ratio (snus versus placebo) for the protocol estimates of cessation varied between 1.9 to 3.4, but these ratios were of borderline significance with p-values ranging from 0.04-0.10. Snus was well tolerated and only 2/158 (1.3%) participants in the snus group discontinued treatment due to an adverse event (in both cases unrelated to snus).Swedish snus could promote smoking cessation among smokers in Serbia, that is, in a cultural setting without traditional use of oral, smokeless tobacco.www.clinicaltrials.gov, identifier: NCT00601042.

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A randomized controlled trial of a manual-only treatment for reduction and cessation of problematic caffeine use.

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A randomized controlled trial of a manual-only treatment for reduction and cessation of problematic caffeine use.

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