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临床试验/NCT07746440
NCT07746440已完成不适用

Impact of Cannabis Withdrawal and Early Abstinence on Threat and Reward Processing

Florida State University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Late Positive Potential

研究概览

简要总结

The goal of this experimental study is to test how three weeks of cannabis abstinence impacts threat and reward processing in females with Cannabis Use Disorder. The main questions it aims to answer are:

Compared to using cannabis as usual, will cannabis cue reactivity increase throughout three weeks of abstinence from cannabis?

Compared to using cannabis as usual, will threat reactivity be elevated at weeks 1 and 2 of abstinence followed by a decrease at week 3 of abstinence?

Compared to using cannabis as usual, will non-drug reward reactivity be lower at weeks 1 and 2 of abstinence followed by an increase at week 3 of abstinence?

Compared to successful 3-week abstainers, will threat, non-drug reward, and cannabis cue reactivity differ in relapsers?

Researchers will compare females with CUD who abstain from cannabis for three weeks to those who continue to use cannabis as usual to see how cannabis abstinence impacts threat and reward processing.

Participants will:

Be randomly assigned to continue using cannabis as usual or abstain from cannabis for three weeks Visit the lab 6 times over three weeks, followed by a 1-month follow-up lab visit for the participants assigned to the cannabis abstinence condition Complete phone surveys every other day across the three week study period

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • >=5 cannabis use days per week on average over the past 3 months
  • >=6 past-year CUD symptoms (must include withdrawal and at least one criterion other than craving must be met within the past 3 months)
  • >=20 days of cannabis use over the past 30 days
  • Positive urinalysis for THC
  • Cannabis is primary substance of abuse

排除标准

  • Current pregnancy
  • History of psychotic, seizure, or cardiovascular disorder
  • Immediate plan to quit cannabis
  • Current treatment for cannabis use
  • Current daily psychotropic medication use
  • Lotion allergy
  • Positive urinalysis for any drug other than THC
  • CSRSS >= 4
  • Current moderate (4+ criteria) or severe (6+ criteria) substance use disorder (SUD) other than CUD or nicotine dependence
  • CBD use >= 9 days

研究组 & 干预措施

Contingency Management for Cannabis Abstinence and Lab Visit Attendance

Experimental

Participants randomly assigned to this arm will receive contingency management for three weeks to reinforce sustained abstinence from cannabis and attendance at all lab visits.

干预措施: Contingency management for cannabis abstinence and lab visit attendance (Behavioral)

Contingency Management for Lab Visit Attendance

Other

Participants randomly assigned to this arm will receive contingency management for three weeks to reinforce attendance at all lab visits. Participants will continue to use cannabis as usual.

干预措施: Contingency management for lab visit attendance (Behavioral)

结局指标

主要结局

Late Positive Potential

时间窗: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up

The Late Positive Potential (neural measure recorded via electroencephalography) will be quantified from \~400 to 3000ms at central-parietal sensors relative to the onset of a cannabis, neutral, unpleasant, or pleasant image. The Late Positive Potential to cannabis vs. neutral and cannabis vs. pleasant will be the primary contrasts of interest.

Reward Positivity

时间窗: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up

The Reward Positivity (neural measure recorded via electroencephalography) will be quantified from \~200-300ms at frontal-central sensors relative to the onset of monetary win and loss feedback. The win vs. loss contrast will be the primary outcome of interest.

Eyeblink Startle Response

时间窗: Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up

The Eyeblink Startle Response (recorded via EMG sensors) will be quantified as the peak blink amplitude relative to the onset of an auditory startle probe during blocks with predictable shocks, unpredictable shocks, and no threat of shock. The Eyeblink Startle Response during unpredictable shock threat vs. no shock threat will be the primary contrast of interest.

次要结局

  • Delta Power(Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up)
  • Delta Intertrial Phase Coherence(Baseline, Week 1, Week 2, Week 3, and (for contingency management abstinence group only) One-Month Follow-Up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rick James Macatee

Principal Investigator

Florida State University

研究点 (1)

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