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- Klinische proef NCT01863095
An Exercise App to Reduce Young Adults' MJ Use
29 januari 2016 bijgewerkt door: R. Lorraine Collins, Ph.D., State University of New York at Buffalo
Use of Exercise to Reduce Young Adult Marijuana Use: There is an App for That
Currently, marijuana (MJ) is the most popular illicit drug, but there are few effective interventions to help young adults (age 18 to 25 years) to reduce their MJ intake.
In this study, we will develop and initially test a smart phone app designed to promote exercise/physical activity as a positive alternative to MJ use.
The app will be tested in an efficacy study in which MJ users are randomly to either receive personalized feedback about MJ use + use the exercise app or personalized feedback only.
The results will contribute to knowledge about exercise/physical activity as a strategy for reducing young adults' MJ use and problems.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Currently, marijuana (MJ) is the most popular illicit drug, with prevalence studies indicating increasing use among young adults (Johnston et al., 2011).
Even so, there are few effective interventions to help MJ users reduce their intake to avoid negative consequences, including MJ dependence.
The investigators propose a Stage 1 efficacy study to develop and initially test an innovative intervention to reduce MJ use among young adults who regularly use MJ (> 3 episodes/week).
The intervention includes elements from the Marijuana Check-Up (MCU; Stephens et al., 2007), a MI-based brief intervention that has shown promise for reducing MJ use.
It also incorporates findings from our ongoing research, which suggest that exercise/physical activity (PA) has potential as a positive alternative to MJ use.
The investigators research also has shown that short (i.e., 10 minute) bouts of moderate or intense exercise reduce craving/urges to use MJ.
Exercise interventions have successfully reduced use of licit substances, such as tobacco (e.g., Marcus et al., 2005) and alcohol (e.g., Brown et al., 2009), but have not been adequately tested for MJ use.
The two aims of this R34 application are: 1) To develop an intervention that consists of four, 60-minute, in-person sessions composed of MCU content (e.g., personalized feedback, MI) as well as a smart phone application (app) that promotes exercise/physical activity (EA) as an alternative to MJ use.
The EA, which will be designed to specifically appeal to young adults, will provide a readily-accessible, flexible, and convenient platform for personalized information and reminders that promote exercise/PA as a positive alternative to MJ use in ongoing daily life.
2) To conduct a pilot/efficacy study of the 4-week MCU+EA intervention vs. a MCU-only control condition.
The investigators will use urn randomization to assign emerging/young-adult MJ users (N = 40) to the two conditions.
During the 1-week baseline, 4-week intervention phase, and 1-, 3-, and 6-month follow-ups, all participants will use the smart phone app to provide real-time data on MJ-related variables and wear accelerometers to provide PA data.
Multilevel modeling will be used to test our hypothesis that the MCU+EA intervention, compared to MCU-only control, will produce greater decreases in quantity and frequency of MJ use (and related MJ problems) at post-intervention and at each follow-up.
Multilevel modeling also will be used to explore the real-time data to examine the role of variables such as urge/craving for MJ, social factors, and dosage of PA in the reduction of the quantity and frequency of MJ use.
This Stage 1 study is unique and innovative in its development and use of a smart phone app to promote and evaluate exercise/PA as a positive alternative to MJ use in daily life.
It includes cutting-edge technology (e.g., accelerometers, smart phone app) for real-time assessments.
This research will make significant contributions to the limited knowledge of exercise/PA as a strategy for reducing MJ use and related problems among emerging and young adults.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
36
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New York
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Buffalo, New York, Verenigde Staten, 14214
- Center for Health Research
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 25 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Regular Marijuana user interested in cutting down on marijuana use
- Body Mass Index < 30
Exclusion Criteria:
- Pregnant or planning to become pregnant
- No legal problems
- No substance abuse diagnosis
- No history of substance abuse treatment
- Medical contraindications to engaging in exercise
- Psychological distress or psychiatric treatment
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Lifestyle counseling
MJ users assigned to this condition will participate in 4 individualized intervention sessions that are based on Motivational Interviewing principles.
They will receive personalized feedback on their MJ use and will be provided a smart phone app on which they report their MJ use episodes, which also is designed to promote the use of exercise/physical activity as an alternative to MJ use.
Level of Physical activity will be measured using accelerometers.
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Actieve vergelijker: Personalized Feedback only
MJ users assigned to this condition will participate in 4 individualized intervention sessions that are based on Motivational Interviewing principles.
They will only receive personalized feedback on their MJ use.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Physical Activity
Tijdsspanne: Change in exercise at 1 month, 3 months, and 6 months after interventionts
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Counts based on data collected by accelerometers.
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Change in exercise at 1 month, 3 months, and 6 months after interventionts
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Substance Use
Tijdsspanne: Change in marijuana use at 1 month, 3 months, and 6 months after intervention
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Change in marijuana use at 1 month, 3 months, and 6 months after intervention
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: R Lorraine Collins, Ph.D., State University of New York at Buffalo
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2014
Primaire voltooiing (Werkelijk)
1 mei 2015
Studie voltooiing (Werkelijk)
1 juni 2015
Studieregistratiedata
Eerst ingediend
21 mei 2013
Eerst ingediend dat voldeed aan de QC-criteria
24 mei 2013
Eerst geplaatst (Schatting)
27 mei 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
1 februari 2016
Laatste update ingediend die voldeed aan QC-criteria
29 januari 2016
Laatst geverifieerd
1 januari 2016
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R34DA035358 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .