Developing a Clinical Outcome Assessment for Opioid Craving
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Change in Acceptability of Craving Assessments
研究概览
简要总结
The purpose of this study is to collect information about opioid craving so that the investigators can develop an opioid craving assessment to improve treatments for individuals with opioid use disorder. To collect this information, the investigators are recruiting individuals in treatment for opioid use disorder who will complete cue-induced opioid craving tasks where these individuals will: (1) look at pictures of neutral objects and touch neutral objects (e.g., water bottles or flashlights), (2) look at opioid-related images, and (3) look and touch opioid-related objects. Participants will then complete a one-on-one interview about the thoughts, feelings and physical sensations the participants experienced during the cue-induced craving session. Participants will also complete questionnaires and existing opioid craving assessments. Finally, participants will provide formal feedback about existing opioid craving assessments with cognitive interviews.
详细描述
There is no universally accepted and validated assessment for opioid craving. Craving is a symptom among individuals with opioid use disorder which can contribute to instances of relapse. More research is needed to develop a valid opioid craving assessment which captures all relevant opioid craving dimensions. Developing a valid, FDA-qualified assessment would support the creation of novel interventions to treat opioid craving and facilitate FDA labeling of a treatment for mitigating opioid craving. To establish content validity, the FDA requires (1) qualitative feedback from stakeholder populations about what should be included in an assessment of opioid craving, and (2) standardized interviews which evaluate participant's acceptability and comprehension of existing assessments of opioid craving. The investigators propose collecting qualitative data in a rigorous laboratory model of cue-induced opioid craving to establish content validity for a craving assessment. Participants (n = 81) will be individuals who are in treatment for opioid use disorder. Participants will attend three outpatient laboratory sessions where the participants will be separately exposed to (1) visual and tactile neutral cues, (2) visual opioid cues, and (3) visual and tactile opioid cues; corresponding to "no", "low", and "high" levels of cue-induced craving. Following cue exposure, participants will be asked to describe in participants' own words the thoughts, moods, and symptoms the participants experience during and after the cue-induced craving task. Next, participants will be asked to complete a brief symptom checklist and rate participants' level of craving for opioids on 9 existing craving questions. Participants will also be asked to provide feedback on existing craving assessments in a standardized interview. Ultimately, these data will identify craving domains experienced across relevant stakeholder populations during both low and high craving bouts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
It is not possible to blind the participant nor some of the research staff to the study condition. The research staff who will interview the participant will be blinded to what cue condition participant had completed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age and older
- •Opioid-positive urine sample at admission visit (excluding individuals receiving Naltrexone).
- •Current opioid use disorder per Diagnostic Statistical Manual (DSM)-5
- •Currently in treatment for opioid use disorder
排除标准
- •Being pregnant or breastfeeding, or may become pregnant during the trial
- •History of psychosis or mania or other serious psychiatric disorders assessed by the Mini International Neuropsychiatric Interview
- •Past 30-day suicidal behavior assessed by the Columbia Suicide Severity Rating Scale
- •Have circumstances that would interfere with study participation (e.g., impending jail).
- •Positive for illicit substances except opioids and cannabis
- •Current substance use disorder other than opioid or nicotine
- •Current intoxication
研究组 & 干预措施
No Craving
Each participant will attend three sessions where the participant will experience three distinct cue-induced craving tasks in a randomized fashion.
干预措施: Visual and Tactile Opioid Cue-induced Craving (Behavioral)
No Craving
Each participant will attend three sessions where the participant will experience three distinct cue-induced craving tasks in a randomized fashion.
干预措施: Neutral Cue-induced Craving (Behavioral)
No Craving
Each participant will attend three sessions where the participant will experience three distinct cue-induced craving tasks in a randomized fashion.
干预措施: Visual Opioid Cue-induced Craving (Behavioral)
结局指标
主要结局
Change in Acceptability of Craving Assessments
时间窗: Sessions 1, 2, and 3 after cue-induced craving task (approximately 1 hour into session)
Responses to the question "What was this question designed to measure?" will be coded by two independent raters as either "Demonstrates understanding" or "Does not demonstrate understanding". Next, responses to the question "What would you change, if anything, about this measure?", will be transcribed and independently coded by two raters as either "no changes needed" or "changes needed". Responses will be compared and incongruencies will be reviewed by a third rater who will make the final designation. If final responses to either question is determined to be either "does not demonstrate understanding" and/or "changes needed", the question will be labeled as unacceptable. For each craving assessment item, the proportion of participants who describe the item as unacceptable will be computed. The proportions of responses designated as "does not demonstrate understanding" and "changes needed" will also be computed.
Change in Craving Domains
时间窗: Sessions 1, 2, and 3 after the cue-induced craving task (approximately 1 hour into session)
Immediately following each cue condition, participants will be asked the following open-ended questions: (1) Describe your mood, (2) Describe how you feel, and (3) What symptoms are you experiencing? Responses will be recorded using a digital audio recorder. Qualitative data collected on the symptoms, moods and feelings following cue-induced craving tasks will be transcribed and independently coded for common craving domains based on our published preliminary study by two raters. Raters will also document other potential domains that do not fit into any of the a priori categories. Ad Hoc domains require that both raters agree that a new category should be created. Independently coded responses will be compared and incongruencies will be reviewed by a third rater who will make the final designation. The types and frequencies of craving domains will be summarized with descriptive statistics.
Change in Deficits in Craving Assessments
时间窗: Sessions 1, 2, and 3 after cue-induced craving task (approximately 1 hour into session)
Responses to the question "What was not captured by these questions that you would include in a measure for assessing opioid craving?" will be coded for themes by two independent raters. Independently coded responses will be compared and incongruencies will be reviewed by a third rater who will make the final designation. The types and frequencies of recommendations will be summarized with descriptive statistics.
次要结局
- Change in Predictive utility of craving assessment items(Sessions 1, 2, and 3 during and immediately after the cue-induced craving assessment (approximately 1 hour into session))