Adaptive Treatment for Alcohol and Cocaine Dependence
1 de agosto de 2017 atualizado por: University of Pennsylvania
Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the full study sample with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use over weeks 1-24.
- Hypothesis 1: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce higher rates of treatment engagement than an intervention focused on engagement in IOP only (e.g., MI-IOP).
- Hypothesis 2: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce better cocaine/alcohol use outcomes than an intervention focused on engagement in IOP only (MI-IOP).
- Secondary analysis 1: Among the Non-engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option.
- Secondary analysis 2: Among the Engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option.
Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC varies as a function of engagement group, with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use outcomes over weeks 1-24.
- Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.
- Hypothesis 2: The predicted main effect on cocaine/alcohol use outcomes favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
3. Secondary objective #1: Examine outcomes on three secondary measures: percent days abstinent from all substances, negative consequences of drug use, and HIV high risk behaviors.
Hypothesis 1: Outcomes on the secondary measures will be better in MI-PC than in MI-IOP.
4. Secondary objective #2: Test hypotheses concerning potential mediators of the predicted main effect favoring MI-PC over MI-IOP.
Hypothesis 1: The predicted advantage of MI-PC over MI-IOP will be mediated by greater increases in motivation, self-efficacy, commitment to abstinence, and self-help involvement in MI-PC.
5. Secondary objective #3: Test hypotheses concerning effect of additional MI intervention after initial non-engagement persists through 12 weeks.
- Hypothesis 1: A second telephone MI intervention will produce higher rates of subsequent engagement and less cocaine use than no further MI.
Tipo de estudo
Intervencional
Inscrição (Real)
500
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Presbyterian Medical Center
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Philadelphia, Pennsylvania, Estados Unidos, 19123
- NorthEast Treatment Center
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- VAMC
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- meet DSM-IV criteria for lifetime cocaine or alcohol dependence and have used cocaine or alcohol in the prior 6 months;
- be > 18 years of age;
- be judged clinically appropriate for IOP (e.g., no current psychotic disorder or evidence of severe dementia, and no acute medical problem requiring inpatient treatment;
- have no regular IV heroin use during the past year;
- have access to a telephone;
- be willing to be randomized and participate in research; and
- no current participation in methadone or other forms of DA treatment, other than IOP. Finally, because of study follow-up requirements, subjects will
- be required to be metropolitan area residents, and
- be able to provide the name, verified telephone number, and address of at least two contacts who can provide locator information on the patient during follow-up. We will include patients with dependence on other substances, provided that they are cocaine dependent and meet other inclusion criteria.
Exclusion Criteria:
- have a current psychotic disorder (as assessed with the psychotic screen from the MINI) or evidence of dementia severe enough to prevent participation in outpatient treatment;
- have acute medical problem requiring immediate inpatient treatment; or
- are currently participating in methadone or other forms of DA treatment, other than IOP.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 1-MI-IOP Engaged
Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.
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2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Outros nomes:
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Experimental: 2-MI-IOP Non-Engaged
Randomized to treatment as usual, and do not attend.
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2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Outros nomes:
one telephone counseling session per week for 10 weeks.
Outros nomes:
One CBT session per week, for 10 weeks.
Outros nomes:
Prescription for naltrexone
Outros nomes:
Return to IOP, group therapy 3 times weekly for about three hours a day.
Outros nomes:
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Comparador Ativo: 3-MI-PC Engaged
Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
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2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Outros nomes:
one telephone counseling session per week for 10 weeks.
Outros nomes:
One CBT session per week, for 10 weeks.
Outros nomes:
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Experimental: 4-MI-PC Non-engaged
Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
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2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
Outros nomes:
one telephone counseling session per week for 10 weeks.
Outros nomes:
One CBT session per week, for 10 weeks.
Outros nomes:
Prescription for naltrexone
Outros nomes:
Return to IOP, group therapy 3 times weekly for about three hours a day.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Treatment Engagement
Prazo: weeks 3 - 12
|
Number of treatment sessions attended
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weeks 3 - 12
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Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks
Prazo: weeks 9 - 12
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Number of treatment sessions attended
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weeks 9 - 12
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Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks
Prazo: weeks 9 - 12
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Number of treatment sessions attended
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weeks 9 - 12
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Any Drinking Days in Previous Month
Prazo: Month 2 (weeks 5 - 8 post baseline)
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Days of any drinking in previous month, as reported on Time Line Follow Back.
This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified.
In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
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Month 2 (weeks 5 - 8 post baseline)
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Any Drinking Days in Previous Month
Prazo: Month 3 (weeks 9 - 12 post baseline)
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Any drinking days during previous month, as reported on Time Line Follow Back.
This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified.
In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
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Month 3 (weeks 9 - 12 post baseline)
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Any Drinking
Prazo: Month 4 (weeks 13 - 15 post baseline)
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Any drinking at follow up, as reported on Time Line Follow Back.
This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified.
In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
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Month 4 (weeks 13 - 15 post baseline)
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Any Drinking
Prazo: Month 5 (weeks 16 - 20 post baseline)
|
Any drinking at follow up, as reported on Time Line Follow Back, This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified.
In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
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Month 5 (weeks 16 - 20 post baseline)
|
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Any Drinking
Prazo: Month 6 (weeks 21 - 24 post baseline)
|
Any drinking at follow up, as reported on Time Line Follow Back.
This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified.
In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
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Month 6 (weeks 21 - 24 post baseline)
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Percent Days Drinking
Prazo: Month 2 (weeks 5 - 8 post baseline)
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Percent days of any drinking at follow up, from Time Line Follow Back
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Month 2 (weeks 5 - 8 post baseline)
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Percent Days Drinking
Prazo: Month 3 (weeks 9 - 12 post baseline)
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Percent days of any drinking at follow up, from Time Line Follow Back
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Month 3 (weeks 9 - 12 post baseline)
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Percent Days Drinking
Prazo: Month 4 (weeks 13 - 16 post baseline)
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Percent days of any drinking at follow up, from Time Line Follow Back
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Month 4 (weeks 13 - 16 post baseline)
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Percent Days Drinking
Prazo: Month 5 (weeks 17 - 20 post baseline)
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Percent days of any drinking at follow up, fromTime Line Follow Back
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Month 5 (weeks 17 - 20 post baseline)
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Percent Days Drinking
Prazo: Month 6 (weeks 21 - 24)
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Percent days of any drinking at follow up, from Time Line Follow Back
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Month 6 (weeks 21 - 24)
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Any Heavy Drinking Days
Prazo: Month 2 (weeks 5 - 8 post baseline)
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days of five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back.
This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified.
In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
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Month 2 (weeks 5 - 8 post baseline)
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Any Heavy Drinking Days
Prazo: Month 3 (weeks 9 - 12 post baseline)
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five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back.
This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified.
In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
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Month 3 (weeks 9 - 12 post baseline)
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Any Heavy Drinking Days
Prazo: Month 4 (weeks 13 - 16 post baseline)
|
five or more drinks per drinking day for men, four or more drinks per drinking day for women at follow up, from Time Line Follow Back.
This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified.
In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
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Month 4 (weeks 13 - 16 post baseline)
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Any Heavy Drinking Days
Prazo: Month 5 (weeks 17 to 20 post baseline)
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five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back.
This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified.
In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
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Month 5 (weeks 17 to 20 post baseline)
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Any Heavy Drinking Days
Prazo: Month 6 (weeks 21 - 24 post baseline)
|
five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back.
This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified.
In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
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Month 6 (weeks 21 - 24 post baseline)
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Percent Days Heavy Drinking
Prazo: Month 2 (weeks 5 - 8 post baseline)
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Percent days heavy drinking at follow up, from Time Line Follow Back *heavy drinking is defined as five or more drinks per day for men, four or more for women |
Month 2 (weeks 5 - 8 post baseline)
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Percent Days Heavy Drinking
Prazo: Month 3 (weeks 9 - 12 post baseline)
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Percent days heavy drinking at follow up, from Time Line Follow Back * heavy drinking is defined as five or more drinks per day for men, four or more for women. |
Month 3 (weeks 9 - 12 post baseline)
|
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Percent Days Heavy Drinking
Prazo: Month 4 (weeks 13 - 16 post baseline)
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Percent days heavy drinking at follow up, from Time Line Follow Back *heavy drinking is defined as five or more drinks per drinking day for men, four or more for women |
Month 4 (weeks 13 - 16 post baseline)
|
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Percent Days Heavy Drinking
Prazo: Month 5 ( weeks 17 - 20 post baseline)
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Percent days heavy drinking at follow up, from Time Line Follow Back * heavy drinking is defined as five or more drinks per drinking day for men, four or more for women |
Month 5 ( weeks 17 - 20 post baseline)
|
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Percent Days Heavy Drinking
Prazo: Month 6 (weeks 21 - 24 post baseline)
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Percent days heavy drinking at follow up, from Time Line Follow Back *heavy drinking is defined as five or more drinks per drinking day for men, four or more for women |
Month 6 (weeks 21 - 24 post baseline)
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Any Cocaine Use
Prazo: Month 3 (weeks 9 - 12 post baseline)
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Any cocaine using self report, binary measure of percent days cocaine use.
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Month 3 (weeks 9 - 12 post baseline)
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Any Cocaine Use
Prazo: Month 4 (weeks 13 - 16 post baseline)
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Any cocaine using self report, binary measure of percent days cocaine use
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Month 4 (weeks 13 - 16 post baseline)
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Any Cocaine Use
Prazo: Month 5 (weeks 17 - 20 post baseline)
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Any cocaine using self report, binary measure of percent days cocaine use
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Month 5 (weeks 17 - 20 post baseline)
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Any Cocaine Use
Prazo: Month 6 (weeks 21 - 24 post baseline)
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Any cocaine using self report, binary measure of percent days cocaine use
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Month 6 (weeks 21 - 24 post baseline)
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Percent Days Cocaine Use
Prazo: Month 3 (weeks 9 - 12 post baseline)
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Percent days of any cocaine use, self reported
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Month 3 (weeks 9 - 12 post baseline)
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Percent Days Cocaine Use
Prazo: Month 5 (weeks 17 - 20 post baseline)
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Percent days of any cocaine use, self reported
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Month 5 (weeks 17 - 20 post baseline)
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Percent Days Cocaine Use
Prazo: Month 6 (weeks 21 - 24 post baseline)
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Percent days of any cocaine use, self reported
|
Month 6 (weeks 21 - 24 post baseline)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: James R. McKay, Ph.D, University of Pennsylvania
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de outubro de 2008
Conclusão Primária (Real)
1 de dezembro de 2013
Conclusão do estudo (Real)
1 de dezembro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
14 de dezembro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de dezembro de 2009
Primeira postagem (Estimativa)
15 de dezembro de 2009
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de setembro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de agosto de 2017
Última verificação
1 de agosto de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 807092
- IND: 101,486
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .