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临床试验/NCT00220350
NCT00220350Unknown2 期

Leuprolide Acetate Suppresses Pedophilic Urges and Arousability

Schober, Justine, M.D.2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2001年10月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
发起方
入组人数
10
试验地点
2
主要终点
suppressed arousal

研究概览

简要总结

This study compared cognitive-behavioral psychotherapy with leuprolide acetate (LA) to cognitive-behavioral psychotherapy with saline injections for 12 months. Five white male pedophiles (M age, 50 years; range, 36-58) volunteered for a two-year study. LA was administered by Depo injection (7 mg initially, then 22.5 mg every 3 mos) for 12 months, followed by saline placebo. Effects of LA on testosterone levels, sexual interest preference by visual reaction time (Abel Assessment), penile tumescence (Monarch PPG), as well strong urges and masturbatory frequency to children (polygraph), were measured every three months. Subjects were treated with weekly cognitive-behavioral psychotherapy. On LA, testosterone decreased to castrate levels. Because of the suppression of testosterone, physiologic arousal response as measured by penile plethysmography (penile tumescence) was significantly suppressed compared with baseline. However, sufficient response remained to detect pedophilic interest. This pedophilic interest was also detected by visual reaction times. All subjects self-reported a decrease in strong pedophilic urges and masturbation. When asked about having pedophilic urges and masturbating to thoughts of children, polygraph responses indicated subjects were not deceptive when they reported decreases. On placebo, testosterone and physiologic arousal eventually rose to baseline levels. At baseline and on placebo, subjects were consistently deceptive regarding increased pedophilic urges and masturbatory frequency as noted by polygraph. Interest preference, as measured by Abel Assessment and Monarch PPG, was generally unchanged throughout the study. Cognitive-behavioral psychotherapy augmented with LA significantly reduced pedophilic fantasies, urges, and masturbation, but did not change pedophilic interest during one year of therapy. Deceptive responses by polygraph suggested that self-report was unreliable. Follow-up utilizing objective measures is essential for monitoring efficacy of treatment in pedophilia. Our study supports the supposition that modification of pedophilic behavior is possible. LA may augment cognitive-behavioral psychotherapy and help break the sequence leading to a reoffense.

详细描述

Hormone therapy is aimed at modification of the basic sex drive, whereas cognitive-behavioral psychotherapy targets cognitive processes that precede all events leading to pedophilic behavior. Obsession/compulsion and sex drive might affect the decision process. Because of a suggested relationship between obsessive compulsive disorder and paraphilias, SSRIs have been utilized. Most reports have been documented from individual case studies or uncontrolled, retrospective studies (Kafka, 2000).

Reports of the efficacy of drug therapy for suppression of sexual drive and modification of behavior continue to emerge. The anti-androgens, MPA and CPA, are the most widely used drugs. They provide variable testosterone suppression, dependent on dose. LHRH inhibitors and GNRH agonists also provide profound testosterone suppression. More recently, triptorelin, an agent similar to LA, (Rosler & Wilztum, 1998) and selective serotonin reuptake inhibitors (SSRIs) have also been investigated (Raymond, Grant, Kim,.& Colemen, 2002; Stein, Hollander, Anthony, Schneier, Fallon, Liebowitz, Klein, 1992).

Despite recent advances in the use of testosterone-suppressing drugs for the treatment of pedophilia, limited information is available in the form of well designed, controlled objective studies. The lack of standardized, objective outcome measures has hampered objective assessment of efficacy of interventions for pedophilia (Briken, Hill, & Berner, 2003; Hanson et al., 2002; Marshall & Barbaree, 1990). A multi-disciplinary team of experts is needed to assess concurrent, objective physiologic measures of response. Though some results of treatment are promising, a reliable, well-tolerated approach that can be objectively monitored for efficacy is lacking.

The specific aspects of behavior that are affected by therapy, as well as the efficacy, limitations, and side effects of treatment need to be determined (Briken, Hill, & Berner, 2003; Raymond, Robinson, Kraft, Rittberg, & Coleman, 2001). The present study assessed the impact of cognitive-behavioral psychotherapy alone versus cognitive-behavioral psychotherapy augmented with a potent testosterone-lowering drug, LA, for suppression of pedophilic urges and arousability. The psychotherapy program comprised cognitive and behavioral therapy. Objective assessments of sexual interest preference and physical arousal, as well as sexual urges and masturbation, were monitored before, during, and after therapy. The research objectives were to explore the relationship between testosterone level and sexual interest preferences, physiologic responses to sexual stimuli (auditory and visual), and self-reported sexual behaviors.

METHOD Subjects Five men (M age, 50 years; range, 36-58), with a diagnosis of pedophilia (American Psychiatric Association, 1994) and who were "out of denial" were recruited for study. Subjects were identified by a focus group of judges, attorneys, Probation and Parole officials, representatives from the District Attorney's office and psychologists who were invited to a seminar regarding the Lupron Project. After potential subjects were identified, the Principal Investigator screened case histories to determine eligibility for study inclusion (Table 1). These potential subjects were contacted by the Principal Investigator. They were interviewed, informed of the study, and invited to participate. Three additional subjects were screened, but excluded. These included one psychotic adult, one adolescent, and one elderly, nonerectile adult. The study was conducted during a two-year period in a medical research center in north western Pennsylvania. The study was reviewed and approved by the local Institutional Review Board. All subjects provided informed consent. Participation was voluntary and not a condition of probation or parole. The subjects were informed that they would receive either a drug or placebo without an indication of duration of dose, the sequence, nor if a sequence would occur. The subjects did not know one another. They lived in diverse geographical locations and their only contact was during group cognitive-behavioral psychotherapy.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • pedohilia admission,healthy,male,adult,ability to have penile response on plethysmography -

排除标准

  • Denial of pedophilia, seizure disorder treated with dilantin or barbiturates, alcoholism, IQ less than 70

结局指标

主要结局

suppressed arousal

次要结局

  • safety

研究者

发起方
Schober, Justine, M.D.
申办方类型
Indiv

研究点 (2)

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