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Cocaine

1. Bianco, Faust. The efficacy of cranial electrotherapy stimulation (CES) for the relief of anxiety and depression among polysubstance abusers in chemical dependency treatment. Ph.D. dissertation, The University of Tulsa, 1994.

Device: LB 2000, 100 Hz, 2mS, <1.5 mA, electrodes behind the ears at the mastoid process

Prior to clinical trials the literature of CES for chemical dependency was subjected to meta-analysis. Initially 180 studies on CES from 1964 through 1987 were reviewed. 8 studies provided the necessary information to calculate means and standard deviations for meta-analysis. The largest effect sizes pertained to the primary withdrawal symptoms of drug use, drug craving, and anxiety specifically among methodone users. In addition the results showed effect sizes beyond that of a placebo effect in several studies relating to anxiety as a secondary withdrawal symptom. However, some studies that considered anxiety as a secondary withdrawal symptom were below the placebo effect level. The analysis displayed an average effect size of 0.940 SD units when comparing CES plus a standard treatment to a CES sham plus a standard treatment, and an effect size of 1.68 when comparing CES plus a standard treatment to standard treatments alone. The average effect sizes for the within groups studies were 0.534 SD units for CES treatments (P<.10), 0.391 SD units for CES sham treatment plus the standard treatment (P<..05) and, 0.171 SD units for the standard treatment alone. The range of the effect sizes for the within group studies were between 0.25 and 0.83 units. The authors concluded that the statistical significance of the within group analysis is quite impressive. To put this into perspective, the average effect size of all psychotherapies are between 0.70 and 0.80 SD units when compared to no treatment (roughly 75% of the pts who receive psychotherapy improve in their condition relative to controls who receive no therapy). The average effect size for non-specific factors or placebo effects among psychotherapies as compared to wait-list controls is about 0.40 SD units.

After achieving IRB approval and informed consent, 65 polysubstance abusers with no history of psychosis were recruited from the Oklahoma Department of Human Services and split into 3 groups for this double-blind study using blinding boxes. Pts were at a lock-in unit at the Chemical Dependency Unit. 36 subjects (18 CES, 16 controls, and 5 sham CES) left AMA. 20 males and 9 females from 20 to 49 years old (mean of 31.3) completed the full course of 45 minutes daily for 6 - 14 days. 9 pts in group 1 (31%) were non-CES controls receiving standard treatment, 9 pts (31%) in group 2 received simulated CES plus standard treatment, 11 pts (38%) received active CES plus standard treatment. The revised Beck Anxiety and Depression Inventories, and the Symptom Check List of the Himmelsbach Scale were administered, along with an attention placebo control interview, and observer-rated measures employed by 2 researchers: the Structured Interview Guide for the Hamilton Anxiety and Depression Scales. In order to achieve a power of .8 (beta = .2), alpha was calculated at .05, effect size at .60, and N at 30 (10 per group). Scheffe tests were performed to determine the significance between the means of each of the 3 groups. There was no significant difference between variables at pretest. Analysis of variance (ANOVA) revealed significant post test group differences. Hamilton Anxiety means for CES pretest was 24.44 9.22 to a post test of 7.09 3.21, for sham CES pretest was 22.56 9.95 and post test was 15.67 7.92, and for controls pretest was 20.56 6.21 and posttest was 16.89 9.06. Scheffe post hoc tests for Hamilton was significant between the CES and controls (P<.05) and between the CES and sham (P<.05), but not the sham and control (P>.05) as measured by the observer ratings. Beck Anxiety post test means were not significant, means for CES pretest was 22.91 10.99 to a post test of 5.27 5.23, for sham CES pretest was 28.78 15.21 and post test was 9.33 7.97, and for controls pretest was 21.44 9.89 and posttest was 9.78 12.17. Although the self reports showed no statistical differences between groups, there was a trend towards significance. The study did not control for medications. The author concluded that the active CES, when combined with the normal treatment regimen given at the treatment facilities was more effective in reducing anxiety and depression than the normal treatment regimen alone and the sham CES plus normal treatment regimen. Thus, the anticipated results regarding CES was supported, while the anticipated results regarding placebo effect was not supported. No side effects were reported.

5. Brovar, A. Cocaine Detoxification with cranial electrotherapy stimulation (CES): A preliminary appraisal. International Electromedicine Institute Newsletter. 1(4), July/Aug, 1984.

Device: Alpha-Stim 350, 0.5 Hz, 50% duty cycle, <500 µA, biphasic rectangular waves, ear clip electrodes

25 consecutive admissions to a drug abuse treatment hospital who qualified for DSM III diagnosis of cocaine abuse were included in the study. Pts were alternately assigned to a control group (N = 12), and Alpha-Stim CES treatment (N =13), of which only 5 accepted while 8 refused. CES was given for 20 minutes twice a day for the 5 day inpatient treatment program. All 5 (100%) of the CES patients completed detoxification, compared with 75% of the other 20. All five (100%) of the CES patients completed the treatment program, compared with 63% of the CES refusers and 67% of the other 12 controls. A follow up of the 3 groups from 6 to 8 months later showed that no CES patients had returned for treatment, while 50% of the CES refusers and 39% of the controls had recidivated. One of the latter had died of overdose. The authors concluded that CES facilitated patient retention in a hospital detoxification and rehabilitation program for cocaine dependent persons. No side effects were reported.

5. Brovar, A. Cocaine Detoxification with cranial electrotherapy stimulation (CES): A preliminary appraisal. International Electromedicine Institute Newsletter. 1(4), July/Aug, 1984.

Device: Alpha-Stim 350, 0.5 Hz, 50% duty cycle, <500 µA, biphasic rectangular waves, ear clip electrodes

25 consecutive admissions to a drug abuse treatment hospital who qualified for DSM III diagnosis of cocaine abuse were included in the study. Pts were alternately assigned to a control group (N = 12), and Alpha-Stim CES treatment (N =13), of which only 5 accepted while 8 refused. CES was given for 20 minutes twice a day for the 5 day inpatient treatment program. All 5 (100%) of the CES patients completed detoxification, compared with 75% of the other 20. All five (100%) of the CES patients completed the treatment program, compared with 63% of the CES refusers and 67% of the other 12 controls. A follow up of the 3 groups from 6 to 8 months later showed that no CES patients had returned for treatment, while 50% of the CES refusers and 39% of the controls had recidivated. One of the latter had died of overdose. The authors concluded that CES facilitated patient retention in a hospital detoxification and rehabilitation program for cocaine dependent persons. No side effects were reported.

64. Smith, Ray B., and Tyson, R. The use of transcranial electrical stimulation in the treatment of cocaine and/or polysubstance abuse. Unpublished, 1991.

No stimulation parameters of CES were given.

146 inpatients were selected in the order of their admission to the hospital. 25% were primary alcohol abusers, while 47% were abusing cocaine. 39 pts were given CES daily for 45 minutes for from 1 to 3 weeks (31 males, 8 females, 14 - 46 years old plus 1, 69 year old, mean = 29.50). 107 pts served as controls (90 males, 27 females, 17 - 49 years old, mean = 29.20). All were pre and posttested on the Profile of Mood States (POMS). Pts treated for 1 week with CES did not differ statistically from the controls on the six POMS subtests. Pts receiving CES for 7 days to 3 weeks improved significantly on all of the 6 POMS subscales. On the Tension-Anxiety subscale the CES group had a mean of 9.00 5.05, while the controls mean was 10.94 7.17 (P<.03). On the Depression-Dejection subscale, the CES group was 10.22 5.48, while the control mean was 15.09 12.28 (P<.0001). On the Anger-Hostility subscale, the CES group was 9.00 5.05, while the control mean was 10.97 7.17 (P<.03). On the Lack of Vigor subscale, the CES group was 13.48 8.82, while the control mean was 14.77 6.50 (P<.03). On the Fatigue-Inertia subscale, the CES group was 5.09 3.91, while the control mean was 8.30 9.25 (P<.0001). On the Confusion-Bewilderment subscale, the CES group was 6.39 3.04, while the control mean was 8.84 5.73 (P<.001). When cocaine pts were analyzed separately, those receiving 7 days to 3 weeks of CES stimulation improved significantly on 4 of the 6 POMS subscales. When cocaine patients were compared with persons with other addictions, no differences in response to CES were found. The authors concluded that CES, which has earlier been shown to be an effective treatment for alcoholic pts, is also effective for pts who have abused drugs in the cocaine family. It can be inferred that CES could function well as a core program element in addiction treatment programs. No side effects were reported.

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