A 12-Week Phase 3 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Tirzepatide-Assisted-Psychotherapy in Adults With Cannabis Use Disorder: A Proof-of-Concept Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Tolerability of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder.
研究概览
简要总结
Cannabis is the most commonly used psychoactive substance in Canada. A sub-group of cannabis users develop Cannabis Use Disorder (CUD). CUD is a pattern of cannabis use that results in impairment in functioning, symptoms of tolerance, withdrawal, and distress. Several pharmacological and psychosocial interventions have been evaluated for their efficacy in treating CUD, however they lack high success rates. GLP-1RA's have shown promising results in reducing food and alcohol cravings and intake. Tirzepatide acts as both a GLP-1RA and a glucose-dependent insulinotropic polypeptide receptor agonist. Tirzepatide has been reported to reduce alcohol consumption, and therefore may have promising effects as a treatment for CUD. This study aims to evaluate the feasibility and tolerability of weekly injections of Tirzepatide combined with Motivational Enhancement Therapy in adults with CUD. This trial will be the first to examine the potential therapeutic effects of Tirzepatide in CUD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 and above
- •DSM-5 Cannabis Use Disorder diagnosis of at least moderate severity (4+ DSM-5 symptoms)
- •4 or more days of cannabis use per week
- •Treatment seeking
- •A Body Mass Index (BMI) ≥ 22
排除标准
- •Meet DSM-5 criteria for Cluster A or B personality disorders and/or unstable current bipolar disorder, schizophrenia, or psychotic disorder
- •Comorbid severe DSM-5 Major Depressive Disorder
- •Present a serious suicide risk or who are likely to require psychiatric hospitalization during the course of the study, as determined by the study physician and Columbia Suicide Severity Rating Scale
- •Any other mental health condition deemed incompatible by the study team
- •Meet DSM-5 criteria for alcohol or substance use disorder for any substance other than cannabis or tobacco in the past 6 months
- •Positive urine drug screen for any substance except cannabis
- •Concurrent addiction-focused psychotherapy in the past 6 months
- •Unstable management of an existing mental health condition or anticipation of a change to the treatment over the next 3 months
- •A personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2
- •Current unstable medical condition
- •A lifetime diagnosis of Diabetes
- •Females who are pregnant/nursing, or individuals in reproductive age who do not consent to using birth control during the study
- •Concomitant treatment with: other GLP-1 agonists, Contrave, bupropion, naltrexone, acamprosate within the past year. No lifetime treatment with tirzepatide.
- •Significant literacy, visual, or hearing problems
- •Co-enrollment in a clinical drug trial
研究组 & 干预措施
Single Arm
This is an open-label single arm intervention. All participants will be offered both Tirzepatide and psychotherapy over the 12-week treatment period.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Tolerability of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder.
时间窗: From baseline to 12-week endpoint.
Tolerability will be measured by the percent of participants who discontinue the trial. Tolerability will also be measured by the percent of participants who reach the target dose.
Feasibility of Tirzepatide-Assisted-Psychotherapy for Cannabis Use Disorder.
时间窗: From baseline to 12-week endpoint.
Feasibility will be evaluated based on the number of people who contact the study team, percent of people that contact who are eligible and percent of eligible participants who enroll.
次要结局
- Frequency and amount of cannabis use(From baseline to 12-week endpoint.)
- Severity of Cannabis Use Disorder symptoms(From baseline to 12-week endpoint)
- Cannabis cravings(From baseline to 12-week endpoint)
- Cannabis withdrawal symptoms(From baseline to 12-week endpoint)
研究者
M. Van Ameringen
Professor
McMaster University