STUDY 2: PILOT STUDY ON CRAVING AND ABSTINENCE
PARTICIPANTS
The subjects were homeless addicts who used the services of the local homeless mission. Signs were posted announcing the study at the mission and all patrons who felt they had a problem with drug addiction were invited to participate. The subjects were informed that there were two different formulas. If they felt that the medication was not effective they could switch to the other formula. They were not told what they were taking but were told that it was a plant extract and proven safe. The subjects were informed that if they joined the study they could quit at any time.
METHODS
The experimental agent was a standardized kava extract with each capsule containing 30 mg kavapyrones. The placebo was a similar looking vitamin capsule. A research assistant packaged 60 capsules of the standardized kava and 60 capsules of the placebo into randomly numbered identical closed containers. Each subject was identified by first name. The medication was distributed by another research assistance that was unaware of which packages contained the experimental medication or the placebo. A basic information sheet was keep for each participant that described the participant by first name and age. The patents drug history was taken and any relevant medical conditions were noted. When the medications were distributed a package was randomly selected and distributed to the subject and the code on the package was noted on the subjects information sheet. These information sheets were given to the first research assistant who read the code and prepared additional medication for the subject when needed.
The subjects were instructed to take one or two capsules every 3 to 4 hours as needed to control their cravings. One third of the test subjects received a placebo. The subjects were required to take the medication for one week to be included in the study. The data was collected weekly. The amount of substance abuse was based solely on the patient’s reports and the clinical appearance of the subject. There was no objective measure of craving. The study was designed to evaluate the subject’s ability to reach abstinence. The assumption was made that if abstinence is achieved in a long-term addict that the carving or desire for the substance of abuse is reduced.
The majority of test subjects entered the data pool in the first two weeks. At five weeks the trends were obvious and the study was concluded. Each subject was then identified as in the placebo or test group. At five weeks anyone who was not abstinent was recorded a failure irrespective of their level of drug use.
RESULTS
Alcohol
Four of the five individuals in the experimental group reached a minimum of two weeks of abstinence. None of the three subjects in the control group reached sobriety. The Pearson chi-square (1) = 3.7, p = .05.
Cocaine -all forms
Four cocaine subjects participated in the study. Two subjects began the study with the placebo but switched in the first week. Two of the subjects achieved abstinence. All subjects reported the medication was effective in reducing their cravings. The results were not statistically significant.
Heroin
The six heroin addicts who began the study were all dropped for non- compliance. None appeared to take the medication for more than a few days.
Tobacco
All individuals in the tobacco study group were also addicted to alcohol, cocaine or heroin. Data was collected on these individuals for their level of intake of their primary addiction and also the amount of tobacco consumed.
Most of the subjects entered the study to stop using cocaine, alcohol or heroin. Very few of the subjects were compelled to quit smoking as they recognized the insignificance of their smoking habit as it relates to their other more serious addiction. Most of the subjects experienced a gradual reduction in smoking as the study progressed.
Of the 10 subjects in the tobacco group three were given a placebo and all switched to kava. Three of the 10 reached two weeks of abstinence during the study. The results were not significant. In the future, in order to draw any valid conclusions, the test group for tobacco will be comprised of individuals only addicted to tobacco and interested in quitting.
The participants of the placebo study groups quickly recognized that they were receiving no benefit from their medication and universally requested to switch to the experimental group. No subjects requested to be switched from the experimental group to the placebo group. At the conclusion of the test all subjects were taking kava.
DISCUSSION
The two studies listed in this article are not intended to be scientifically valid. The purpose of the two investigations was to determine if further study is warranted. In spite of the very small sample size the results for the alcohol group was the most promising and produced a P=.05. The cocaine patients gave positive reports of the effectiveness of kava to reduce their carving however due to the sample size no conclusions can be drawn.
The amount of kava supplied in the second study would be considered a subclinical dose. It is likely the participants did feel a mild relaxation from 60 mg of kavapyrones as it was prescribed. However, this feeling would be nearly imperceptible when compared to one bowl of kava prepared in a traditional manner, which contains approximately 400 mg of kavapyrones. In spite of the low dose all participants recognized that they were getting some benefit from the experimental medication and all patients on the placebo soon requested to switch to kava. No participants requested to be switched form kava to the placebo.
Addiction is a significant health risk for the Hawaiian people and most other Pacific cultures. The population utilized for the preliminary studies were subjects who have repeatedly failed to recover from their addiction in spite of numerous attempts at rehabilitation. The subjects were comprised of the complete spectrum of ethnic and economic backgrounds. The only seemingly common trait amongst the subjects was that they all have lost everything as a result of their addiction.
Many ancient cultures developed addictive substances. These substances ranged from seemingly innocuous substances such as caffeine to devastating substances such as heroin. However, the ancient cultures of Hawaii and the Pacific Islands appear to have avoided addictive substances until they were introduced from the outside. The ancient Polynesians traveled extensively and it is likely they came into contact with substances such as betel nut and other addictive substances. There can be many reasons for this lack of addictive substances in many of the ancient Pacific cultures. One possible explanation would be that no addictive substances were available in the environment or that the Polynesians were never exposed to addictive substances from nearby cultures. Another possible explanation is that the Polynesians had developed a successful antidote for addiction in kava.
The presentation of this preliminary information will hopefully encourage further research into the use of kava for the treatment of addictions. The studies presented in this report have limited scientific value and do not allow for any meaningful conclusions in regard to kava’s usefulness in the treatment of addictions.
REFERENCES
1. Gossop M, Powell J, Grey S, Hajek P. What do opiate addicts and cigarette
smokers mean by "craving"? A pilot study. Drug and Alcohol Dependence,
1990; 26(1): 85-7.
2. Uebelhack R, Franke L, Schewe HJ. Inhibition of platelet MAO-B by kava
pyrone-enriched extract from Piper methysticum Forster (kava-kava). Pharmacopsychiatry, 1998; 31(5): 187-92.
3. Volz HP, Kieser M. Kava-kava extract WS 1490 versus placebo in anxiety
disorders in a randomized placebo-controlled 25-week outpatient trial. Pharmacopsychiatry, 1997; 30: 1-5.
4. Warnecke G. Psychosomatic dysfunctions in the female climacteric.
Clinical effectiveness and tolerance of Kava Extract WS 1490. Fortschritte Der Medizin, 1991; 109(4): 119-122.
5. Baum SS, Hill R, Rommelspacher. Effect of kava extract and individual
kavapyrones on neurotransmitter levels in the nucleus accumbens of rats. Progress in Neuropsychopharmacology and Biological Psychiatry, 1998; 22(7):
1105-1120.
6. Seitz U, Schule A, Gleitz J. [3H]-monoamine uptake inhibition properties
of kava pyrones. Planta Medica, 1997; 63: 548-549.
7. Jamieson DD, Duffield PH. The antinociceptive actions of kava components
in mice. Clinical and Experimental Pharmacology and Physiology, 1990;
17(7): 495-507.
8. Kretzschmar R, Meyer HJ. Comparative studies on the anticonvulsant
activity of the pyrone compounds of Piper methysticum Forst. Archives of
International Pharmacodynamics, 1969; 177: 261-267.
9. United States Patent #5585386. Rosedbaum,G. Alpha-pyrone compositions for
inducing/stimulating hair growth and/or retarding hair loss. Paris, France.1996
10. Steiner GG. The correlation between cancer incidence and kava
consumption. Hawaii Medical Journal, 2000; 59(11): 420-422.
11. Mark Blumenthal, Senior Editor. The complete German Commission E
monographs, Therapeutic guide to herbal medicines. American Botanical
Council, Boston, Mass.; 1998.
12. Norton SA, Ruze P. Kava dermopathy. Journal of the American Academy of
Dermatology, 1994; 31(1): 89-97.
13. Lebot V, Merlin M, Linstrom L. Kava the Pacific Drug. Yale
University Press ,New Haven, Connecticut; 1992: 10.
14. Jussofie A, Schmiz A, Hiemke C. Kavapyrone enriched extract from
Piper methysticum as modulator of the GABA binding site in different regions
of rat brain. Psychopharmacology, 1994; 116(4): 469-474.
15. Boonen G, Haberlein H. Influence of genuine kavapyrone enantiomers on the
GABA-A binding site. Planta Medica, 1998; 64(6): 504-506.
16. Walden J, von Wegerer J, Winter U, et al. Effects of kawain
and dihydromethysticin on field potential changes in the hippocampus. Progress in Neuro-psychopharmacology and Biological Psychiatry, 1997;
21(4): 697-706.
17. Bruggemann F, Meyer HJ. Die analgetische wirkung der
kawa-inhaltsstoffe dihydrokawain und dihydromethistizin. Arzneimittelforschung, 1963; 13: 407-409.
18. Woelk H et al., 1993, Volz HP et al., 1997. Woelk H,
Kapoula S, Lehrl S, et al. Treatment of patients suffering from
anxiety in a double-blind study: Kava special extract versus
benzodiazepines. Ztschr Allegemeinmed, 1993; 69: 271-277.
19. Heinze HJ, Munthe TF, Steitz J, et al. Pharmacopsychological
effects of oxazepam and kava-extract in a visual search paradigm assessed with
event-related potentials. Pharmacopsychiatry, 1994; 27: 224-230.
20. Munte TF, Heinze HJ, Matzke M, et al. Effects of oxazepam and an
extract of kava roots (Piper methysticum) on event-related potentials in a word
recognition task. Neuropsychobiology, 1993; 27: 46-53. |