Creating the Chinese version of the transgender attitudes and beliefs scale.

BACKGROUND: Trans persons' physical and mental health is easily affected by the attitude of those around them. However, China currently lacks a valid psychometric instrument to investigate people's attitudes toward trans persons. Therefore, this study modifies the English version of the Transgender Attitudes and Beliefs Scale (TABS) to suit the Chinese context. It subsequently examines the reliability and validity of the Chinese version of the TABS. METHODS: This study recruited 1164 university students, aged 18-25 years, from 7 regions of China. SPSS26.0 and AMOS24.0 were used for data statistical analysis. Critical ratio method and correlation coefficient method were used for item analysis. Exploratory factor analysis and confirmatory factor analysis were used to test the structural validity of the Chinese version of Transgender Beliefs and Attitudes Scale, and the internal consistency reliability of the scale was tested. RESULTS: The TABS-C contains 26 items with 3 factors. The Cronbach's alpha was 0.957 for the total scale and 0.945, 0.888, and 0.885 for the 3 factors. The half-point reliability of the scale was 0.936, and the retest reliability was 0.877. The Pearson correlation coefficients for the 3 factors and the total scale score ranged from 0.768 to 0.946. CONCLUSION: The TABS-C has reliable psychometric properties and is suitable for usage among college students in the Chinese context.

A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to verify the efficacy and safety of ansofaxine (LY03005) for major depressive disorder.

Major depressive disorder (MDD) is the most prevalent form of depression and is becoming a great challenge for public health and medical practice. Although first-line antidepressants offer therapeutic benefits, about 35% of depressed patients are not adequately treated, creating a substantial unmet medical need. A multicenter, double-blind, randomized, placebo-controlled phase 3 clinical trial was conducted in patients with MDD in China to assess the efficacy and safety of ansofaxine (LY03005), a potential triple reuptake inhibitor of serotonin, norepinephrine, and dopamine. Eligible 588 MDD patients were included and randomly assigned (1:1:1) to 8-week treatment with ansofaxine 80 mg/day(n = 187), ansofaxine 160 mg/day(n = 186), or placebo(n = 185). The primary efficacy endpoint was the Montgomery-Åsberg Depression Rating Scale (MADRS) total score change from baseline to the end of the study. Safety indexes included adverse events, vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), and evaluation of suicide tendency and sexual function. Significant differences were found in mean changes in MADRS total score at week 8 in the two ansofaxine groups (80 mg, -20.0; 160 mg, -19.9) vs. placebo (-14.6; p < 0.0001). All doses of ansofaxine were generally well-tolerated. Treatment-emergent adverse events (TEAEs) were reported by 137 (74.46%) patients in ansofaxine 80 mg group, 144 (78.26%) patients in ansofaxine 160 mg and 125 (67.93%) patients in the placebo group. The incidence of treatment-related adverse events (TRAEs) was 59.2% (109 patients), 65.22% (120 patients) in the 80, 160 mg ansofaxine groups, and 45.11% (83 patients) in the placebo group. The initial results of this trial indicate that ansofaxine at both the 80 mg/day and 160 mg/day was effective and safe in adult patients with MDD. ClinicalTrials.gov Identifier: NCT04853407.

Association of functional COMT Val108/Met polymorphism with smoking cessation in a nicotine replacement therapy.

Nicotine replacement treatment (NRT) can be efficacious for smoking cessation, but used by only a minority of smokers in China. Pharmacogenetic matching may improve treatment outcomes for NRT in subgroups of smokers. We evaluated the efficacy and safety of sublingual nicotine tablets (SNT) for smoking cessation and the association of catechol-O-methyltransferase (COMT) genotype with efficacy in this smoking cessation trial among Chinese smokers. We conducted a double-blind, placebo-controlled, 8-week trial of SNT with a follow-up at week 12 among 250 Chinese smokers. Efficacy and safety were evaluated at day 4 and weeks 2, 4, 6, 8, and 12. Abstinence was biochemically verified by exhaled carbon monoxide (CO) and urine cotinine. The COMT Val108Met genotype was determined as a restriction fragment length polymorphism. Our results showed that the success rates for complete abstinence were greater for active versus placebo treatments at 8 weeks (48 vs. 17 %) and 12 weeks (52 vs. 19 %) (both p < 0.0001). Craving was significantly reduced from week 2 on active treatment compared to placebo. Adverse events were mild and tolerable. We found a genotype by treatment interaction at 12 weeks with greater abstinence rates in the COMT Val/Val (50 vs. 15 %) than the Met/Val + Met/Met genotypes (46 vs. 25 %). We found that SNT significantly increased smoking abstinence, reduced craving and was well tolerated, and the COMT Val/Val genotype was associated with a greater improvement in smoking cessation.

Effects of acute combined serotonin and dopamine depletion on cue-induced drinking intention/desire and cognitive function in patients with alcohol dependence.

BACKGROUND: Alcohol cues can precipitate the desire to drink and cause relapse in recovering alcohol-dependent patients. Serotonin and dopamine may play a role in alcohol cue-induced craving. Acute combined tryptophan (Trp), tyrosine (Tyr), and phenylalanine (Phe) depletion (CMD) in the diet attenuates the synthesis of serotonin and dopamine in the human brain. However, no study of the effects of acute CMD has been previously conducted. Therefore, we investigated whether the attenuation of serotonin and dopamine synthesis changes cue-induced alcohol craving in recently abstinent alcoholics. METHODS: In this double-blind, randomized, placebo-controlled, crossover design, 12 male patients who met the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, criteria for alcohol dependence were divided into two conditions: (1) monoamine depletion (i.e., consumption of a concentrated amino acid beverage that resulted in a rapid and significant decrease in plasma-free Tyr/Phe/Trp) and (2) balanced condition (i.e., consumption of a similar beverage that contained Tyr/Phe/Trp). The participants were scheduled for two experimental sessions, with an interval of ≥7 days. The cue-induced craving test session was conducted 6h after each amino acid beverage administration. Drinking urge, blood pressure, heart rate, working memory, and attention/psychomotor performance were assessed before and after administration. RESULTS: Compared with the balanced condition, the monoamine depletion condition significantly increased drinking intention/desire and diastolic blood pressure. Cognitive performance was not different between the two conditions. CONCLUSIONS: Acute combined serotonin and dopamine depletion may increase drinking intention/desire and diastolic blood pressure without influencing cognitive function.

Long-term treatment with aripiprazole on the waking and postprandial urges to smoke in Chinese heavy smokers.

The central dopaminergic system plays a critical role in the reinforcing effects of nicotine, which are key determinants in the urge to smoke. Previous study has demonstrated that immediate administration of 10-mg aripiprazole significantly decreased various subjective responses to smoking. The present study investigated whether 2-week treatment with 10-mg aripiprazole could attenuate waking and postprandial urges to smoke in Chinese male and female heavy smokers. A randomized and placebo-controlled pilot clinical study was conducted to assess the effect of aripiprazole on various responses to smoking. The primary outcomes were subject's ratings on questionnaires of smoking urge, withdrawal syndromes, and cigarette evaluation. All participants were administered either placebo or 10-mg aripiprazole for 2 weeks. Throughout the experiment, participants were required to self-report (1) smoking urge and nicotine withdrawal symptoms before their first cigarette after awakening and after lunch and (2) subjective responses to the first cigarette smoked of the day and after lunch. Aripiprazole was associated with significantly decreased waking and postprandial urges to smoke. Aripiprazole failed to produce a significant effect on overall nicotine withdrawal symptoms after awakening and after lunch. However, waking, but not postprandial, withdrawal craving and syndromes were significantly reduced by aripiprazole. Aripiprazole had no effect on the overall subjective responses to the first cigarette of the day and after lunch. The attenuating effects of aripiprazole on waking and postprandial urges to smoke demonstrate the promising effect of aripiprazole in the treatment of nicotine dependence.

Family support and employment as predictors of smoking cessation success: a randomized, double-blind, placebo-controlled trial of nicotine sublingual tablets in chinese smokers.

BACKGROUND: The purpose of this study is to assess social support and demographic factors that influence the success of smoking cessation aided with sublingual nicotine tablets in a Han Chinese population. METHODS: We randomly allocated 211 Beijing residents who smoked >or= 10 cigarettes a day for at least 1 year into a double-blind, placebo-controlled 3-month randomized smoking cessation trial using sublingual nicotine replacement therapy (NRT). Self-reports of sustained smoking cessation were verified during the study by expired carbon monoxide concentrations and urine-cotinine concentrations. Logistic regression analysis used an intent to treat sample for sociodemographic associations with abstinence and reduction in smoking. RESULTS: The abstinence rates at the end of treatment for NRT vs. placebo were 52 % vs .19%, and smoking reduction (reduced to at least 50% of baseline) rates for NRT vs. placebo were 43% vs .15% for a total response rate with NRT of 95% for either stopping completely or reducing smoking by 50%. The only factor strongly associated with successful smoking cessation after 3 months of sublingual NRT was being married (adjusted odds ratio 2.18; 95%confidence interval 1.10-4.33). Smoking association, on the other hand, was associated with being married and with employment as a white collar worker (2.24; 1.03 to 4.86). CONCLUSIONS: These findings suggest the need for a more in-depth examination of the impact of being married and employment as a white collar worker (rather than manual laborer) in order to develop better targeted interventions for improving smoking cessation interventions.

Subjective, cognitive/psychomotor, and physiological effects of aripiprazole in Chinese light and heavy smokers.

BACKGROUND: Drug addiction researchers have begun to study dopamine partial agonists as potential therapeutic agents. The partial dopamine D(2) receptor agonist aripiprazole has recently been tested as a treatment for stimulant and alcohol dependence in both animal and clinical studies. METHODS: A randomized and placebo-controlled pilot clinical study was conducted in a population of Chinese light and heavy smokers to assess the effect of aripiprazole on various responses to smoking. The primary outcomes were subject's ratings on questionnaires of smoking urge, withdrawal syndromes, and cigarette evaluation. Placebo, 5, and 10mg aripiprazole were acutely administered in all participants, with administrations at least 7 days apart. Subjective responses to a smoked cigarette, working memory, and attention/psychomotor performance were assessed before and after drug administration in each experimental session. Abstinence-induced smoking urge, withdrawal symptoms, blood pressure, and heart rate were also measured every 45 min after drug administration. Finally, a cue-testing session was carried out 4h after each drug administration. RESULTS: Administration of 10mg aripiprazole significantly decreased both the subjective response and psychological reward derived from smoking a cigarette in heavy smokers. While neither 5 nor 10mg aripiprazole significantly decreased abstinence-induced smoking urges or withdrawal symptoms in light and heavy smokers, these doses substantially attenuated drug cue-induced smoking urges in heavy smokers. Aripiprazole did not affect working memory or attention/psychomotor performance. CONCLUSIONS: Light and heavy smokers responded differently to aripiprazole across various dependent measures. Aripiprazole may potentially affect various subjective responses to smoking in heavy smokers.