Targeting Anhedonia in Cocaine Use Disorder - Treatment Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Number of Participants Who Were Cocaine Abstinent as Assessed by Urine Screening (Measure of Treatment Efficacy)
研究概览
简要总结
The purpose of this study is to examine anhedonia as a potential moderator of treatment outcomes for Cocaine Use Disorder (CUD). Specifically, this study will investigate how anhedonia affects outcomes in contingency management (CM) treatment for CUD and whether anhedonia mediates the effects of adjunctive treatment with a dopaminergic (DAergic) drug, d-amphetamine, on outcomes in CM for CUD, as well as investigate the contribution of anhedonia to overall CUD severity.
详细描述
Recent research suggests that anhedonia is a key neurobehavioral dysfunction in Cocaine Use Disorder (CUD) that contributes to treatment outcomes. Anhedonia, defined here as lack of interest or pleasure in non-drug rewards, is frequently found in CUD and is related to neural deficits, such as low striatal dopamine and deficient activation to non-drug rewards in mesocortical circuits. Interestingly, not all individuals in CUD have these deficits. Preliminary data suggests that the presence of self-reported anhedonia predicts worse outcome in contingency management (CM) treatment of CUD. Moreover, low baseline dopamine predicts failure to attain abstinence in CM while medications that enhance DA increase CM success rates and responsiveness to rewards.
This study specifically aims to test the contribution of anhedonia to overall CUD severity, the relationship of anhedonia to outcomes in CM treatment, and the mediating role of anhedonia in medication enhancement of CM in CUD. To accomplish these aims, individuals with CUD will be enrolled and will undergo 4 weeks of intensive CM treatment, either with or without treatment with the dopaminergic drug, d-amphetamine. A medication only group will be included to solely measure the effects of d-amphetamine. Anhedonia will be assessed using multi-modal subjective, psychophysiological and behavioral measures of reward functioning at baseline, and each week of treatment. Functional magnetic resonance imaging (fMRI) measures of reward functioning will also be taken at baseline and week 4 in a subset of participants (n = 24)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be between 18 and 60 years of age
- •meet Diagnostic and Statistical Manual V (DSM-5) criteria for current cocaine use disorder of at least moderate severity (≥ 4 symptoms)
- •have at least 1 cocaine positive urine sample during the baseline screening period
- •be in acceptable health on the basis of interview, medical history and physical exam, per the judgment of our study physician
- •be able to understand the consent form and provide written informed consent
- •be able to provide the names of at least 2 persons who can generally locate their whereabouts.
- •if female, agree to use an acceptable method of birth control during study (surgical sterilization, approved hormonal contraceptives, barrier methods with spermicide, or intrauterine device).
排除标准
- •current DSM-5 diagnosis for substance use disorder of least moderate severity (≥ 4 symptoms), other than cocaine, nicotine, marijuana, or alcohol
- •Physical dependence on alcohol requiring medically supervised detoxification, in the judgment of the study physician
- •current amphetamine use (by self-report in past 30 days or positive urine drug screen), more than 50 lifetime uses of amphetamine, or history of DSM-5 Amphetamine Use Disorder
- •a current DSM-5 axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
- •significant current suicidal or homicidal ideation
- •medical conditions contraindicating d-amphetamine (e.g., significant cardiovascular disease, liver or kidney disease, seizure disorder, hypotension or hypertension)
- •taking medications known to have effects on the central nervous system or that could cause significant drug interactions with d-amphetamine (e.g., clonidine, prazosin)
- •having conditions of probation or parole requiring reports of drug use to officers of the court
- •impending incarceration
- •pregnant or nursing for female patients
- •inability to read, write, or speak English
- •Additional Exclusion Criteria for the functional magnetic resonance (fMRI) Sub-Study (in addition to all listed criteria above for the Main Treatment Study):
- •body mass index (BMI) >30, as this may be incompatible with the magnetic resonance scanner gantry
- •any retained metals in the body, including implants and metallic substances (e.g. aneurysm clips, retained metal particles in metal workers, magnetic dental implants, ferromagnetic ocular implants, iron-based facial tattoos), as this may cause adverse effects to participants and interfere with data collection in the MR magnetic field
- •inability to tolerate small, enclosed spaces (such as the magnetic resonance scanner bore)
研究组 & 干预措施
d-Amphetamine and Contingency Management
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine with contingency management treatment for cocaine use disorder.
干预措施: d-amphetamine (Drug)
d-Amphetamine and Contingency Management
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine with contingency management treatment for cocaine use disorder.
干预措施: Contingency management (Behavioral)
d-Amphetamine alone
Participants in this group will receive 4 weeks of treatment with 60mg of sustained release d-amphetamine but will not receive contingency management treatment for cocaine use disorder.
干预措施: d-amphetamine (Drug)
Placebo and Contingency Management
Participants in this group will receive 4 weeks of of placebo treatment, paired with contingency management treatment for cocaine use disorder.
干预措施: Contingency management (Behavioral)
Placebo and Contingency Management
Participants in this group will receive 4 weeks of of placebo treatment, paired with contingency management treatment for cocaine use disorder.
干预措施: Placebo (for d-amphetamine) (Drug)
结局指标
主要结局
Number of Participants Who Were Cocaine Abstinent as Assessed by Urine Screening (Measure of Treatment Efficacy)
时间窗: At end of active treatment (Treatment week 4)
Subjects will complete a urine drug screen each visit. Achievement of cocaine abstinence will be defined as two consecutive weeks of cocaine-negative urine samples.
次要结局
- Cocaine Negative Urine Samples(At end of active treatment (Treatment week 4))
研究者
Margaret.C.Wardle
Assistant Professor
University of Illinois at Chicago