Open-label Feasibility Trial of HD-tDCS During Cognitive Behavioral Therapy for Cocaine Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cocaine use
研究概览
简要总结
Cocaine Use Disorder (CocUD) is a significant public health issue with increasing cocaine-related overdose mortality. Effective treatments for CocUD are highly needed. One understudied target for CocUD therapeutics is improving cognitive function (CF) in that key theories attribute development of CocUD and other substance use disorders (SUD) to impaired CF, such as decreased ability to inhibit behavior. Heavy cocaine users show impairments in attention, working memory, planning, and response inhibition, affecting as many as 30-80% of individuals with SUD. These cognitive deficits affect patient engagement and participation in SUD treatment, thus necessitating SUD programs assess and accommodate cognitive problems throughout treatment.
详细描述
Among persons with SUD, those with low CF show more attentional bias toward reward-associated cues, where relapse may stem from reward circuit activation by drug cues that is insufficiently checked by the neurocircuitry of the dorsolateral prefrontal cortex (DLPFC) thought to regulate behavior. Many skills for SUD recovery taught in cognitive behavioral therapy (CBT) are reliant on DLPFC directed top-down regulation, such as recognizing environmental triggers and recalling more healthy coping strategies. However, a challenge for CBT is poor encoding, retention and in situ invocation of these skills. Of interest is improving brain function in these individuals to assist in CBT effectiveness. One option is to use stimulants which have been shown to reduce cocaine use, but they have abuse potential. It is thus critical to discover safer neurobiological interventions that could improve CBT success without risking problematic interactions with commonly prescribed psychotropic medications.
A promising neurobiological intervention for CocUD is transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique that induces changes in neuronal excitability via hypo- or hyper-polarization of underlying resting membrane potentials, resulting in lasting changes in network connectivity that extend beyond the stimulated brain region. When applied over DLPFC, tDCS has been shown to increase memory recall and other CF in older adults with mild cognitive impairment. In SUD, tDCS has also reduced stimulant craving compared to sham stimulation and to reduce rates of relapse in crack cocaine users. In persons with methamphetamine use disorder, tDCS over DLPFC reduced cue-induced drug craving, and this reduction correlated with tDCS-reinforced functional connectivity in the executive control brain network. Thus, tDCS may improve CBT encoding and adherence without potential side effects and abuse potential of medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Randomization will occur once eligibility has been confirmed during visit. The first participant will be randomized by flipping a coin. Subsequent participants will be randomized by alternating based on the last participant randomized.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 65 years-of-age.
- •Meet current DSM-5 criteria for Cocaine Use Disorder (CocUD), moderate or severe
- •Professed interest in CocUD treatment or reducing cocaine use.
- •Understand and comply with study procedures
- •Positive urine result for cocaine metabolite in at least one screening visit.
排除标准
- •Current DSM-5 diagnosis of any non-cocaine substance use disorder (SUD) other than alcohol use disorder-mild or cannabis use disorder-mild
- •Epilepsy or a history of multiple seizures
- •Taking any medications known to reduce seizure threshold
- •History of migraines, ringing in the ears, and/or a head injury that resulted in a diagnosis of concussion and/or loss of consciousness
- •Current scalp condition (e.g. psoriasis) or head wound that has not completely healed
- •Currently pregnant or hoping to become pregnant at any point during the study
- •Significant current suicidal or homicidal ideation
- •Metal plate in skull or other embedded metal fragments in body or other bodily metal
- •Claustrophobia or other MRI contraindications
- •Fitted with electrical implants such as pacemaker
- •Present with clinically significant symptoms of acute cocaine or opioid withdrawal (these individuals would be rescheduled after resolution of acute withdrawal, if possible).
研究组 & 干预措施
Left-DLPFC HD-tDCS
Electrode locations are standardized across participants using the International 10-20 EEG System
干预措施: High Definition Transcranial Direct Current Stimulation (Device)
Right-DLPFC HD-tDCS
Electrode locations are standardized across participants using the International 10-20 EEG System
干预措施: High Definition Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Cocaine use
时间窗: Baseline Task Visit, Baseline MRI Visit, during 8 HD-tDCS CBT visits, Follow-up MRI visit, Debrief visit (1 week after Follow-up MRI visit)
Subjects will be monitored for cocaine-positive urine sample, proportion of the visit samples that are negative for cocaine metabolites.
次要结局
- Medication Compliance(Baseline Task Visit, Baseline MRI Visit, during 8 HD-tDCS CBT visits, Follow-up MRI visit, Debrief visit (1 week after Follow-up MRI visit))