Tests of a Therapeutic Cocaine Vaccine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Cocaine Intoxication
研究概览
简要总结
Clinical data demonstrate that a cocaine vaccine (TA-CD: Celtic Pharmaceutical) produces selective anti-cocaine antibodies, yet the impact of these antibodies on cocaine's direct effects is unknown. The objective of this human laboratory study was to measure the relationship between antibody titers and the effects of smoked cocaine on ratings of intoxication, craving and cardiovascular effects.
Cocaine-dependent volunteers not seeking drug treatment spend 2 nights per week for 13 weeks inpatient where the effects of cocaine (0, 25, 50 mg) are determined prior to vaccination and at weekly intervals thereafter. Vaccinations occur at weeks 1, 3, 5 and 9.
详细描述
I do not desire to provide a more extensive description.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets DSM-IV criteria for current cocaine dependence. The volunteer may meet criteria for other substance abuse, but not dependence (other than nicotine).
- •Primary route of cocaine administration is smoking.
- •Females must be surgically sterilized or post- menopausal
- •Able to give informed consent, and comply with study procedures.
排除标准
- •Dependence on substances other than cocaine or nicotine.
- •Judged to be noncompliant with study protocol.
- •History of autoimmune disease, immune deficiency or hypersensitivity to other vaccines. An HIV test must be negative.
- •Currently uses drugs intravenously
- •Currently taking any psychotropic medication
- •Laboratory tests that are clinically unacceptable to the study physician (BP > 140/90; BUN, creatinine, LFTs > 1.5 ULN; hematocrit < 34 for women, < 36 for men)
- •Blood or blood products given in the three months prior to vaccination
- •Other vaccines, including flu vaccine, given within 30 days of screening.
- •Ongoing active infection
- •Currently taking immunosuppressives -
研究组 & 干预措施
Low dose Vaccine
All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 82ul
干预措施: Cocaine vaccine (TA-CD) (Biological)
High Dose Vaccine
All participants were vaccinated four times: in week 1, 3, 5, and 9. Dose: 360ul
干预措施: Cocaine vaccine (TA-CD) (Biological)
结局指标
主要结局
Cocaine Intoxication
时间窗: 13 weeks
Visual Analogue Scale ratings (0-100mm) of the Good Drug Effect cluster ("Good Drug Effect," "High," "Stimulated") over 13 weeks as a function of cocaine dose (25mg or 50mg). Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate more agreement with the statements.
次要结局
- Plasma Cocaine(13 weeks)
- Cocaine Cardiovascular Effects(13 weeks)