Riluzole for treatment of men with methamphetamine dependence: A randomized, double-blind, placebo-controlled clinical trial

Background: Riluzole is a glutamate regulator and effective in treatment of neuropsychiatric conditions. Aims: We assessed riluzole for treatment of methamphetamine dependence. Methods: In this randomized, double-blind, placebo-controlled clinical trial, male outpatients with methamphetamine dependence who were 18–65 years old received either 50 mg riluzole ( n=34) or placebo ( n=54) twice daily for 12 weeks. Patients were excluded in case of comorbid serious medical conditions or neurologic disorders, comorbid psychiatric disorders other than methamphetamine dependence requiring specific treatment interventions, simultaneous positive urine test result for substances of abuse other than methamphetamine, smoking >3 days per week, simultaneous consumption of medications which are contraindicated or have interaction with riluzole. Results: Concerning primary outcomes, the cumulative mean number of attended weekly visits was higher in the riluzole arm compared with the placebo arm approaching a statistically significant difference (riluzole, median (range)=13.00 (2.00–13.00); placebo=4.00 (2.00–13.00); Mann-Whitney U=505.00, p-value=0.073), and the weekly measured rate of positive methamphetamine urine test results was significantly lower in the riluzole arm by the end of the study (riluzole=1 (5.00%), placebo=9 (45.00%), p-value=0.004). Patients in the riluzole arm experienced significantly greater improvement on all the craving, withdrawal, and depression measures regarding mean score changes from baseline to endpoint. No significant difference was detected between the two arms in terms of incidence of adverse events. Conclusion: Future randomized clinical trials are needed to investigate proper dosing strategy in a more inclusive sample.

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A novel botanical formula improves eye fatigue and dry eye: a randomized, double-blind, placebo-controlled study

American Journal of Clinical Nutrition ◽

10.1093/ajcn/nqaa139 ◽

2020 ◽

Vol 112 (2) ◽

pp. 334-342 ◽

Cited By ~ 1

Author(s):

Juntao Kan ◽

Min Wang ◽

Ying Liu ◽

Hongyue Liu ◽

Liang Chen ◽

...

Keyword(s):

Clinical Trial ◽

Dry Eye ◽

Controlled Study ◽

Controlled Clinical Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Eye Fatigue ◽

Nutritional Strategy ◽

Significant Difference ◽

Break Up

ABSTRACT Background With the frequent use of video display units, eye fatigue is becoming more common globally. An alternative nutritional strategy is needed to prevent the aggravation of eye fatigue symptoms. Objectives The objective was to evaluate the protective effect of a novel botanical combination of lutein ester, zeaxanthin, and extracts of blackcurrant, chrysanthemum, and goji berry on adults with eye fatigue in a randomized, double-blind, placebo-controlled clinical trial. Methods We randomly allocated 360 participants into 4 groups to receive placebo and 3 doses of our formula (chewable tablets, containing 6 mg, 10 mg, or 14 mg of lutein) once daily for 90 d. Each participant had 3 visits at baseline (V1), 45 d (V2), and 90 d (V3) during the study. Results Intervention with the formula improved individual scores of eye fatigue symptoms, including eye soreness, blurred vision, dry eye, foreign body sensation, and tearing. Compared with placebo, the formula at all 3 doses significantly decreased the total score of eye fatigue symptoms and increased the visuognosis persistence time at both V2 and V3. According to the Schirmer test, both 10-mg and 14-mg lutein formula groups had improved tear secretion at V3 compared with the placebo. The keratography results indicated that the first tear break-up time, average tear break-up time, and tear meniscus height were significantly increased after formula intervention. The formula at all 3 doses significantly increased the macular pigment optical density at V2 and V3 compared with the placebo, whereas optical coherence tomography showed no significant difference in retinal thickness and retinal volume across all groups at both visits. Conclusions Our botanical formula improves eye fatigue, dry eye, and macular function without changing the retinal structure, and thus it could serve as an effective nutritional strategy in improving eye fatigue without causing serious side effects. Clinical Trial Registry: chictr.org.cn (ChiCTR1800018987).

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Efficacy of gabapentin mouthwash in managing oral mucositis pain in patients undergoing chemotherapy: a prospective, randomised, double-blind, controlled clinical trial

Scottish Medical Journal ◽

10.1177/0036933019897237 ◽

2020 ◽

Vol 65 (1) ◽

pp. 12-18

Author(s):

Shahram Ala ◽

Neda Zamani ◽

Jafar Akbari ◽

Ebrahim Salehifar ◽

Ghasem Janbabai ◽

...

Keyword(s):

Clinical Trial ◽

Pain Intensity ◽

Oral Mucositis ◽

Controlled Trial ◽

Sufficient Evidence ◽

Controlled Clinical Trial ◽

Significant Activity ◽

Double Blind ◽

Double Blind Placebo ◽

Significant Difference

Background and aims Gabapentin has been used for the management of radiotherapy and chemotherapy induced stomatitis in a number of studies. Due to lack of sufficient evidence, the present study was designed to evaluate the efficacy of gabapentin mouthwash in oral mucositis associated pain in patients undergoing cancer chemotherapy. Methods and results This study was a prospective, randomised, double-blind, placebo-controlled trial. The patients were randomly divided into two groups receiving either the gabapentin or placebo mouthwash. Patients were advised to rinse their mouth with 7 ml of solution for 30 s three times a day and were visited 10 days after initiation of the trial. The intensity of pain and severity of oral mucositis were assessed. Thirty-one patients received gabapentin mouthwash while 27 patients received placebo. Both gabapentin and placebo mouthwashes had decreased the pain intensity almost equally and did not show a significant difference between the two groups (P = 0.73). Also both gabapentin and placebo had reduced and improved swallowing, inflammation and erythema. But there was no noticeable difference between groups (P > 0.05). Conclusions These findings indicate that gabapentin mouthwash did not show a significant activity as a pain relieving agent in chemotherapy induced oral mucositis associated pain.

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