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Polysubstance Abusers

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.

2. Braverman, E, Smith, R., Smayda, R, and Blum, K. Modification of P300 amplitude and other electrophysiological parameters of drug abuse by cranial electrical stimulation. Current Therapeutic Research. 48(4):586596, 1990.

Device: HealthPax, 100 Hz, 20% duty cycle, 1.0 mA, no dc bias, square waves, electrodes at left wrist and forehead

Electrophysiological abnormalities are said to be hallmarks of the high risk individual for drug abuse and the drug abuser. P300 waves occur 300 mS after a cognitive auditory potential and have been shown to have a reduced amplitude in many alcoholics, which does not revert to normal even after continued abstinence. Earlier research has concluded that the need to modify these electrophysiological parameters could be of critical importance in the treatment and possibly the prevention of drug abuse. In this study 13 alcohol and/or drug abusers (9 - 81 years old, mean of 43.44) and 2 staff controls were selected as they entered the clinic for brain electrical activity mapping (BEAM, a computerized EEG). After providing informed consent, all were given 40 minutes of CES between preand postCES BEAM scans. There was no significant changes in the controls. Following CES the pts P300 amplitude increased significantly (P<.05) as analyzed by Fisher test of probability which compared the differences between the means and variances. The time went from a pretreatment of 308 24 to 317 26 msec post treatment. The amplitude (dV) went from pretreatment of 7.0 4.1 to 9.9 6.0 post treatment. Also, there were significant positive shifts in alpha, delta, theta and beta spectra in patients who were abnormal in one or more of these areas prior to CES treatment. It was concluded that CES might be a significant nondrug treatment for the underlying electrophysiological disorder of the drug abuser, because the normalization of these electrophysiological parameters are characteristic of pharmaceutical treatment. The authors concluded that they believe the future is bright for prescriptive electricity, and that the electrophysiological changes that occur as a result of CES have the greatest implication for American's # 1 health problem, drug abuse. No side effects were reported.

31. Magora, F., Beller, A., Assael, M.I., Askenazi, A. Some aspects of electrical sleep and its therapeutic value. In Wageneder, F.M. and St. Schuy (Eds). Electrotherapeutic Sleep and Electroanaesthesia. Excerpta Medica Foundation, International Congress Series No. 136. Amsterdam, Pages 129-135, 1967.

Device: 30 - 40 Hz, 2 mS, 2 mA, forehead to occipital fossa electrodes

20 hospitalized pts suffering from long-lasting insomnia with anxiety, obsessive and compulsive reactions, morphine and barbiturate addiction and involutional depression were given 2 - 4 CES treatments weekly for 2 - 3 hours a day for a total of 10 - 20 treatments. 5 of the 20 showed no improvement, 11 had sedative effects, and 4 had hypnotic effects. The 15 responders all had normal restoration of their sleep rhythm as measured by EEG. Parallel with the return to a normal sleep pattern, all the other psychiatric signs: anxiety, depression, agitation, delusions, abstinence syndrome, improved so that all these pts were able to leave the hospital. Follow-up has continued for 8 - 12 months after treatment and has revealed no relapse.

Also 9 children (aged 5 - 15 years) suffering from severe, long-lasting bronchial asthma, resistant to conventional treatment, including steroids, were given 3 - 24 (Av. 15) CES treatments once a week for 1 - 2 hours. The asthmatic attacks stopped completely in 3 children and 4 months later the children felt well without taking any drugs. 2 children showed objective improvement, no wheezes were found on examination and, the frequency and severity of wheezing spells were diminished. 1 child showed slight improvement, 2 did not respond at all. None suffered an asthmatic attack for 24 hours following CES. Placebo conditions did not cause any improvement. The authors concluded that it appears that CES may be an adjunct to the treatment of asthma in children. Because of the selection for trial of the most severe cases available to us, resistant to any other known treatment, even slight results are encouraging. It was also noted that no ill-effects were noted on prolonged and repeated observations in dogs and in humans.

36. May, Brad, and May, Carole. Pilot project using the Alpha-Stim 100 for drug and alcohol abuse. August, 1993.

Device: Alpha-Stim 100, 0.5 Hz, 50% duty cycle, biphasic rectangular wave, ear clip electrodes

14 male volunteers in 2 recovery homes for several days to 7 months received 25, 1 hour Alpha-Stim CES treatments. Multiple Affect Adjective Check List (MAACL) means showed a significant and dramatic decline in the anxiety scores by mid test dropping from 4.07 pretest to 1.00 mid test and 1.00 post test. Depression (3.42 pretest to 0.79 mid- and post test) and hostility scores (2.43 pretest to 0.71 mid- and post test) were also reduced significantly, while significant increases were seen in self-worth, feeling expression, and capacity for intimate contact. The Beck Depression Inventory dropped from 14.50 pretest to 5.00 midtest to 3.50 post test. The investigator commented that verbal feedback was equally exciting. One participant said afterwards, "something inside me has shifted and I just know I'm never going to take another drink of alcohol again." Another said, "I've been sober for about 75 days , but it feels like I've been sober for years." No side effects were reported.

51. Schmitt, Richard, Capo, Thomas, Frazier, Hal, and Boren, Darrell. Cranial electrotherapy stimulation of cognitive brain dysfunction in chemical dependence. Journal of Clinical Psychiatry. 45(2):60-63, 1984.

Device: Neurotone 101, 100 Hz, 2 mS, <1 mA, electrodes behind each ear

This doubleblind study involved 60 alcohol and polydrug abuser inpatient volunteers with an average age of 33.9. Treatment effects were assessed pre- and post test on the Revised Beta Examination and 3 subscales of the WAIS that are clinical indicators of organic brain syndrome (digit span, digit symbol, and object-assembly). 88% of the pts were initially dysfunctional on 1 or more of the 3 WAIS scales, with 63% dysfunctional on 1 or more of the Beta subtests. 40 pts received CES or sham CES treatments, and a third, control group of 20 participated in the normal hospital program without access to CES devices. The study was completed by 87% of the CES treated pts (N = 26), 60% of the sham-treated pts (N = 6), and 85% of the controls (N = 17). It was noted that 80% of the sham-treated pts, but only 20% of the treated pts had complained about the ineffectiveness of CES treatment. Following the study, 2 of the complaining sham pts were given CES and they both said it was a highly effective treatment with WAIS testing supporting these claims. Using Fisher's t-tests (P<.01), CES treated pts made significant gains on all measures of brain function over and above the two control groups. No placebo effects were found. Significant gains were also made on the Revised Beta Examination I.Q. test among CES patients but not by the controls. The authors concluded by agreeing with Dr. Ray Smith's speculation that a treatment program in which patients are treated specifically for cognitive dysfunction is not only humane but can add to the effectiveness of the other treatment modalities in a treatment and rehabilitation setting. No side effects were reported.

52. Schmitt, Richard, Capo, Thomas, Boyd, Elvin. Cranial electrotherapy stimulation as a treatment for anxiety in chemically dependent persons. Alcoholism: Clinical and Experimental Research. 10(2):158-160, 1986.

Device: Neurotone 101, 100 Hz, 20% duty cycle, <1 mA, electrodes behind each ear

60 inpatient alcohol and/or polydrug abusers (mean age = 33.9) volunteered for this double-blind study. 30 were given CES, 10 sham CES, and 20 served as normal hospital routine controls. Dependent measures of anxiety were the Profile of Mood States, the IPAT Anxiety Scale, and the State Trait Anxiety Index. The CES and sham pts received 15 daily, 30 minute treatments. Based on Fisher t-tests of the means, CES treated patients showed significantly greater improvement on all anxiety measures than did either control group. There were no differences in response between older and younger patients, or between the primarily drug or alcohol abusers. No placebo effect was found on any of the measures. The authors concluded that CES is rightfully gaining increasing use in American medicine as it gains increasing confirmation as a significant treatment adjunct for stress and cognitive dysfunction in chemical dependency treatment programs, regardless of the chemical of abuse or the age range of the patients treated. 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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