Department of Psychiatry, Columbia University Medical Center, New York, NY, USA; New York State Psychiatric Institute, New York, NY, USA.
New York State Psychiatric Institute, New York, NY, USA.
Drug Alcohol Depend. 2021 Oct 1;227:108933. doi: 10.1016/j.drugalcdep.2021.108933. Epub 2021 Jul 27.
In clinical trials of pharmacotherapy for substance use, abstinence is the primary endpoint accepted by regulatory agencies. However, this endpoint could be overly restrictive, impeding efforts to identify effective medications for cocaine use disorder. To examine non-abstinent gradations in cocaine use as potential indicators of improvement, we investigated the relationship of frequency of cocaine use to clinical correlates in national survey data.
Lifetime cocaine users (n = 2501) were interviewed in the National Epidemiological Survey on Alcohol and Related Conditions (NESARC) in 2001-2002 and re-interviewed in 2004-2005. Adjusted odds ratios (aORs) indicated associations between heaviest frequency of cocaine use and use of other substances, DSM-IV substance use disorders, psychiatric disorders, and change between 2001-2002 and 2004-2005. The reference category for all aORs was non-users.
Greater lifetime cocaine use frequency was associated with lifetime cocaine, alcohol, and cannabis dependence (aOR for a linear trend = 2.80, 1.22, 1.22, respectively) and past-year cocaine, alcohol, and cannabis dependence (aOR = 1.78, 1.13, 1.16, respectively). Greater lifetime cocaine use frequency was associated with past-year depressive, panic, and generalized anxiety disorders (aOR = 1.07, 1.09, 1.12, respectively). Among cocaine users in 2001-2002, compared to the reference group using less than monthly, use ≥1x/week and use 1-3 times a month was associated with cocaine use disorder in 2004-2005 (aOR = 2.13 and aOR = 1.67, respectively).
Gradations in risk for dependence on cocaine, other substances and psychiatric disorders by frequency of cocaine use indicates a promising direction for more sensitive outcome measures of treatment effects on cocaine outcomes than binary indicators (e.g., any use vs. none). Study results add to findings suggesting that non-abstinent measures might be useful indicators of treatment efficacy in clinical trials.
在药物治疗物质使用障碍的临床试验中，戒断是监管机构认可的主要终点。然而，这个终点可能过于严格，阻碍了识别可卡因使用障碍有效药物的努力。为了研究可卡因使用的非戒断程度作为改善的潜在指标，我们调查了全国调查数据中可卡因使用频率与临床相关性的关系。
2001-2002 年在国家酒精与相关条件流行病学调查（NESARC）中对终生可卡因使用者（n=2501）进行了访谈，并于 2004-2005 年进行了重新访谈。调整后的优势比（aOR）表明，一生中可卡因使用最频繁与其他物质的使用、DSM-IV 物质使用障碍、精神障碍以及 2001-2002 年至 2004-2005 年之间的变化有关。所有 aOR 的参考类别均为非使用者。
一生中可卡因使用频率越高，与可卡因、酒精和大麻依赖（线性趋势的 aOR 分别为 2.80、1.22 和 1.22）以及过去一年可卡因、酒精和大麻依赖（aOR=1.78、1.13 和 1.16）相关。一生中可卡因使用频率越高，与过去一年的抑郁、惊恐和广泛性焦虑障碍（aOR=1.07、1.09 和 1.12）相关。在 2001-2002 年的可卡因使用者中，与参考组相比，使用频率<每月一次、每周使用≥1 次和每月使用 1-3 次与 2004-2005 年的可卡因使用障碍相关（aOR=2.13 和 aOR=1.67）。
按可卡因使用频率划分的对可卡因、其他物质和精神障碍的依赖风险梯度表明，与二元指标（例如，任何使用与无使用）相比，更敏感的治疗效果对可卡因结果的衡量指标是一个有前途的方向。研究结果增加了发现，表明非戒断措施可能是临床试验中治疗效果的有用指标。
