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Cochrane Database of Systematic Reviews Protocol - Intervention

Managed alcohol as a harm reduction intervention for alcohol addiction in populations at high risk for substance abuse

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To assess the effectiveness of Managed Alcohol treatment regimes (serving limited quantities of alcohol daily to alcoholics) on their own or as compared to moderate drinking (self controlled drinking), screening and brief intervention using a harm reduction approach and traditional abstinence based interventions ( 12 step programs) and no intervention.

Background

Alcohol abuse is defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM‐IV) as a destructive pattern of alcohol use occurring within a 12 month period, resulting in repetitive maladaptive behaviour and leading to significant social, occupational, or medical impairment. The alcohol abuser still has control over his/her use of alcohol and has not developed tolerance. Alcohol dependence (alcoholism) occurs when an individual has lost control over his/her use of alcohol and its consumption becomes the dominant focus in his/her life, causing deterioration of occupational, psychological, and/or social functioning.
DSM‐IV diagnosis of alcohol dependence requires users to meet the criteria for alcohol abuse plus have three or more of the following: (1) Tolerance ‐ the need to increase amounts of alcohol consumed to achieve the desired effect; (2) Withdrawal ‐ the experience physiological and psychological symptoms when alcohol consumption is stopped and/or use alcohol consumption to avoid or reduce specific symptoms; (3) Uncontrolled behaviour ‐ alcohol is consumed in larger amts or for longer than intended; (4) Cravings ‐ persistent desire or unsuccessful efforts to cut down or control alcohol use; (5) A lot of time is spent to procure, use, or recover from the effects of alcohol consumption; (6) Important social, occupational, or recreational activities given up or reduced because of alcohol use; (7) Continues alcohol use despite knowledge of persistent physical or psychological problems worsened by alcohol.

Alcohol dependence is a fairly common disorder, with a prevalence of 2.6% in the general Canadian population (Tjepkema 2004). This prevalence increases in vulnerable populations to 5.1% in low income households (annual income <$10,000), and 16.2 % in mentally ill (Kandel 2001; Tjepkema 2004). The World Health Organisation states that approximately 76.3 million persons have alcohol use disorders worldwide (WHO 2007).

Alcoholic dependence is three to four times higher in individuals with a family history of alcohol abuse compared with the general population (DSM‐IV). Furthermore, studies have found that alcohol abuse is as high as 53‐73% in the homeless adult (Cordray 1993; Farrell 2000; Gelberg 1993).

These figures are clinically and socially significant because alcohol misuse (abuse or dependence) influences not only the health and social outcomes of these individuals but also impact their families, local communities and society at large. Alcohol dependence contributes to binge drinking, consumption of non‐beverage alcohol (i.e. mouthwash, cleaning products, cough and cold remedies), violent and/or criminal behaviors, suicide, job instability, poor compliance with treatment, longer hospital stays, homelessness, public inebriation, increased emergency room visits and mortality (Caton 2005; D'Amore 2001; Egbert 1985; Hibbs 1994; Kushel 2001; Mandelberg 2000). The World and Health Organisation (WHO 1999; WHO 2002), estimates that alcohol causes 3.2% of deaths worldwide, with a global cost to health above that of tobacco. Medical consequences of alcoholism include oesophageal cancer, liver cancer, chronic ulcers, cirrhosis of the liver, epilepsy, psychotic breakdown, increased rates of hospitalization, and shorter life expectancy (Hibbs 1994; Kushel 2001; WHO 2002).

Currently, a number of different behavioural interventions are used to treat individuals suffering from alcohol dependence. These include: Traditional Abstinence (zero tolerance), Screening and Brief Intervention, Moderate Drinking, and Managed alcohol (harm reduction).

Alcoholics Anonymous (AA) is the classic example of a traditional abstinence program, whereby a self‐help group of recovering alcoholics offer emotional support and an effective 12 step model for the achievement of abstinence (A.A. 2001). The 12 steps for personal recovery, assume that alcohol dependence is a spiritual and medical disease. It is a zero‐tolerance program that consists of a structured approach to facilitating recovery from alcohol abuse ([A.A. 2001).

Brief interventions involve a time‐limited motivational intervention focusing on changing an individual's alcoholic behaviour. It uses counselling skills to encourage a reduction in alcohol consumption and the problems associated with alcohol misuse. A brief intervention can range from five to ten minutes of information and advice to a maximum of three sessions of motivational interviewing or counselling by a health care professional.

Moderate Drinking is a self‐help program that supports non‐abstinence goals. It relies on the ability of an alcoholic to return to a decreased or more controlled pattern of alcohol consumption due to their own initiative (Doufor 1999). In this program, the onus is on the individual to examine how drinking has affected their life, identify their life priorities, and set moderate drinking limits once they understand what their "drinking pattern" has been (i.e. how much, how often, and under what circumstances). Often the decision to control their alcohol intake is induced by health concerns, family or relationship problems, poor work productivity, or driving difficulties (Saladin 2004).

The successful treatment of alcoholism using traditional abstinence, brief Intervention, or moderate drinking methods is dependant on positive prognostic factors such as good social functioning (i.e. established/functional family relationship, lack of legal problems, employment), motivation, and/or good health status. In contrast, characteristics commonly found in vulnerable populations, such as psychiatric co‐morbidity, lack of stable housing, unemployment, lack of motivation, and/or the presence of chronic medical conditions are negative prognostic factors (Stahler 1995). In order to combat this, harm reduction approaches to the treatment of alcoholism, such as Managed Alcohol Programs (MAP), have gained more attention as traditional treatment methods are not as successful in treating vulnerable populations (i.e. chronically homeless) (Ambrogne 2002).

Harm reduction programs meet the individual "where they are at" to help them (a) understand the risks involved in their behaviour and (b) make decisions bout their own treatment goals. Instead of making abstinence from alcohol an objective, the harm reduction approach seeks to (1) minimize the personal harm and adverse societal effects that alcohol dependence can lead to, (2) provide an alternative to zero‐tolerance approaches by incorporating drinking goals (abstinence or moderation) that are compatible with the needs of the individual, and (3) promote access to services by offering low‐threshold alternatives, which enable clients to gain access to services despite continued alcohol consumption (Marlatt 2002). Following these objectives, MAPs serve alcoholics controlled amounts of alcohol on a daily schedule, as a way to ensure that individuals consume safe alcoholic beverages in a safe environment (Hass 2001; Podymow 2006; Wilton 2003).

Studies have found that MAPs can reduce drinking, the number of hospital admissions, ER visits, and police incidents, while improving the overall health of homeless individuals suffering from alcoholism (Hass 2001; Podymow 2006; Wilton 2003). These studies demonstrate that controlled access to alcohol, in a safe environment may be the most effective treatment for: (1) retaining vulnerable populations in treatment programs, (2) decreasing their alcohol consumption, and (3) show some evidence of effectiveness towards other relevant outcomes such as decreasing criminal activity, seeking regular medical care, and improving quality of life.
To date, there has been no systematic, controlled analysis of the effects of harm reduction programs on treatment of alcohol dependence among individuals classified as vulnerable.

The question of whether harm reduction approaches (i.e. MAP) in the treatment of alcohol dependence results in better outcomes versus more standard treatment regimes (traditional abstinence‐based, brief interventions, or moderate drinking) remains unanswered. In addition, whether the harm reduction approach is more effective in vulnerable populations than the general population is also unknown.

The aim of the present review is to identify, synthesize, and evaluate the effectiveness of a harm reduction approach as compared to the standard treatment programs, in reducing the incidence of harmful behaviours in vulnerable individuals suffering from alcohol dependence.

Objectives

To assess the effectiveness of Managed Alcohol treatment regimes (serving limited quantities of alcohol daily to alcoholics) on their own or as compared to moderate drinking (self controlled drinking), screening and brief intervention using a harm reduction approach and traditional abstinence based interventions ( 12 step programs) and no intervention.

Methods

Criteria for considering studies for this review

Types of studies

Relevant randomized control studies (RCT) and controlled clinical trials (CCT) comparing types of interventions will be included. As blinding and randomized control studies may be difficult to achieve, cluster clinical trails with control groups will be considered and separately analysed ‐ it is understood that these study designs do not have perfect randomization. Based on the Cochrane Drugs and Alcohol Group guidelines, Interrupted time series (ITS) studies and Control Before and After (CBA) studies will be included using EPOC criteria only if RCTs or CCTs are not found or very few are found (fewer than 5). Papers, reports, abstracts, brief and preliminary reports will be considered for inclusion if they describe a study with the appropriate study design. Grey literature will have to meet the study inclusion criteria. Studies will be eligible for inclusion if they include a comparison of the study intervention (Managed Alcohol) to a different type of intervention or no treatment.

Types of participants

Vulnerable people age 18 year or older who are at high risk for alcohol abuse will be included. Alcohol abuse is defined here according to the World Health Organisation International Classification of Diseases (ICD 10 R). In this, alcohol abuse or alcoholism includes craving, physiological signs, such as tolerance and withdrawal, and behavioral indicators such as the use of alcohol to relieve withdrawal discomfort, as well as harmful use, implying alcohol use that causes either physical or mental damage in the absence of dependence. Vulnerable populations considered at high risk will include those who are homeless, impoverished, mentally ill, those with a family history of alcohol addiction, family dysfunction or disruption, foetal alcohol spectrum disorder (FASD), past exposure to trauma. These will include people with multiple drug addictions, co‐morbidities including mental health problems.

Types of interventions

Experimental Interventions

  • Managed Alcohol, defined as a structured program which provides clients with controlled amount of alcohol on a daily schedule.

Control Interventions

  • Moderate drinking, defined as a treatment approach where people suffering from alcohol dependency learn to control their alcohol intake themselves

  • Brief intervention, defined as up to three sessions involving an alcohol and a health care professional comprising of information, advice, counselling to encourage a reduction in alcohol consumption and problems associated with alcohol mis‐use.

  • Twelve‐step programs defined as a program that provide a structured approach to achieving abstinence from alcohol. These programs can be either self help (Alcoholics Anonymous) or professionally led. The twelve step programs include attending group meetings, reducing drinking, remaining abstinent and addressing social problems related to alcohol consumption.

  • No Intervention

Types of outcome measures

Primary outcomes
Reduction in incidence of harmful behaviour. Harmful behaviour includes binge drinking, substance abuse, violence/aggression, drinking non‐beverage alcohol, failure to adhere to medication, incarceration, death, reduction in drinking‐self reported or program data, abstinence

Secondary outcomes
Reduction in incidence of anti‐social behaviour, begging, violence, aggression, sex trade work, criminal activity, disruption in the community, public inebriation, social functioning,

Search methods for identification of studies

We will search the following electronic databases:
(1) Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2007) which includes the Cochrane EPOC and Drugs and Alcohol Group Trials Registers ;
(2) MEDLINE (January 1966 to June 2007);
(3) EMBASE (January 1988 to June 2007);
(4) CINAHL (1982 to June 2007);
Search strategies for electronic databases are being developed with selected MeSH terms and free text terms.

The following are the data terms that will be used in the MEDLINE search strategy, combined with a methodological search filter.
Alcohol program
1. alcoholism/
2. (alcoholic or alcoholism).tw.
3. ((alcohol) adj2 (abuse$ or addict$ or dependen$))
4. 1 or 2 or 3
5 . program evaluation/
6 . program$.tw.
7 . treatment regim$.tw.
8 . (managed adj2 treatment).tw.
9 . (treatment adj2 regim$).tw.
10 . managed alcohol.tw.
11 . brief intervention.tw.
12. moderate drinking.tw.
13. self‐help groups/ or alcoholics anonymous/
14. intervention$.tw.
15. (daily adj alcohol).tw.
16. Temperance/
17. abstinence.tw.
18. twelve‐step.tw.
19. 5/18 OR
20. 4 and 19
combined with the phases 1 & 2 of the Cochrane Sensitive Search Strategy for the identification of RCTs as published in Appendix 5b2, Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2006):
21.randomized‐controlled‐trial.pt
22.controlled‐clinical‐trial.pt
23.exp randomized‐controlled‐trials/
24.exp random‐allocation/
25. exp double‐blind‐method/
26.exp single‐blind‐method/
27.21 or 22 or 23 or 24 or 24 or 25 or 26
28.exp clinical trials/
29.clinical trial.pt
30.(clin$ adj2 trial$).ti,ab
31.(singl$ or doubl$ or trebl$ or tripl$) adj (blind$ or mask$).ti,ab
32.exp placebos/
33.placebo$.ti,ab
34.random$.ti,ab
35.exp research‐design
36.28 or 29 or 30 or 31 or 32 or 33 or 34 or 35
37.27 or 36
38.20 and 37
39.limit 38 to human

This search strategy will be translated into the other databases using the appropriate controlled vocabulary as applicable. We will not have any language restrictions.

Other sources:
Hand searching of those high‐yield journals and conference proceedings which have not already been hand searched on behalf of the Cochrane Collaboration.
Reference lists of all papers and relevant reviews identified.
References to ongoing and recently finished clinical trials will be identified by searching the National Research Register, IFPMA Clinical Trials Database which contains ClinicalTrials.gov, Centerwatch, Current‐Controlled‐Trials and ClinicalStudyResults.gov, Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali.
Authors of relevant papers will be contacted regarding any further published or unpublished work. Authors of other reviews in the field of effective professional practice will be contacted regarding relevant studies that they may be aware of.

Data collection and analysis

Selection of Studies
We will collate all study citations into a single data base. Two authors will independently screen titles and abstracts and select references potentially relevant to the review. Differences between selection lists will be resolved by discussion. We will obtain copies of each potentially relevant article. We will order full reports of citations with inadequate information to definitively determine relevance. Two authors will independently revaluate whether studies should be included or excluded according to the eligibility criteria. In the event of a disagreement, a third author will be consulted.

Data extraction and management
Two reviewers will independently extract data from the full text report using a pilot tested data extraction form based on the Cochrane Effective Practice and Organisation of Care (EPOC) review group. Disagreements will be resolved by discussion and consultation with a third reviewer. Where possible, we will extract data which records effects by socio‐economic position, and by other socio‐demographic variables, including place of residence, gender, race/ethnicity, and age.

Dealing with missing data
If the included study article does not include details on characteristics of methodology, study population or necessary data for statistically analysis, we will contact investigators to collect missing data.

Assessment of methodological quality of included studies
Study quality will be assessed according to the criteria indicated in the Cochrane Reviewers' Handbook (Cochrane Handbook).

Two reviewers will independently assess the quality of each study design using the EPOC checklist (EPOC 2007) and methods outlined in the protocol by Kristjansson 2007.
Specifically, in assessing methodological quality of RCTs, allocation concealment, baseline measurement, reliable primary outcomes measure, blinded assessment of primary outcomes, protection against contamination, co‐intervention and loss of follow‐up will be considered. These will be scored met, unclear or unmet.

  • CBAs will be considered based on baseline measurement, blinded assessment or primary outcomes, reliability of outcomes measures, co‐intervention, and protection against contamination. These will be scored met, unclear or unmet.

  • ITS designs will be assessed according protection against secular changes, protection against detection bias, reliability of the outcome measures, co‐intervention, and completeness of data set. These will be scored met, unclear or unmet.

Studies will be classified as A (low risk of bias), B (moderate risk of bias) and C (high risk of bias) (Cochrane Handbook) based on allocation concealment:
A. Low Risk of Bias : Adequate Allocation Concealment
B. Moderate Risk of Bias : Unclear concealment
C. High Risk of Bias : Inadequate concealment or Not Used
Definitions for allocation concealment
A.Adequate concealment ‐ Allocation of participants to different groups was not known until the point of allocation (e.g. sequentially numbered, sealed, opaque envelopes; onsite computer system with locked, unreadable files)
B.Unclear concealment (e.g. stating only that a list or table was used)
C.Inadequate concealment ‐ Transparent before allocation (e.g. alternation; case record numbers; dates of birth or days of the week)
D.Not used ‐ clear that allocation concealment was not used

In addition to this, we will use a narrative review technique to further explore the quality of included studies. As part of this narrative summary, we will set out the strengths, weaknesses, and contributions of each study in a tabular form.

Measures of treatment effect
For dichotomous data, the overall relative risk (95% CI) will be calculated. Weighted mean difference will be calculated for continuous data (95% CI). If outcome measure instruments are similar but not identical, standard mean difference will be calculated.

Assessment of heterogeneity
In order to assess heterogeneity, we will use the following methods (outlined in Kristjansson 2007):
(1) Common sense (e.g. are the interventions, participants or outcomes so different that they cannot be combined?). This will be based on a synthesis of the process elements.
(2) Chi‐square test for heterogeneity (p<0.10) and I‐Squared (Higgins 2003), a quantity which describes approximately the proportion of variation in point estimates that is due to heterogeneity rather than sampling error. We will supplement this with a test of homogeneity to determine the strength of evidence that the heterogeneity is genuine.
(3) Visual examination of graphs for outliers and between study differences.

Assessment of reporting biases
Publication bias will be assessed using funnel plots.

Sensitivity analysis
Sensitivity analysis will be conducted to consider methodological quality criteria used for study inclusion. Studies with methodological flaws will be excluded.

Results from different study designs (RCT, CBA, ICT) will not be combined. Sub‐group analysis will be performed. As outlined in the Cochrane Handbook, sub‐group analysis will only be conducted if a sufficient number of studies are found.