Cannabis DependenceLifecareNCT04513756
Efficacy of Community Reinforcement Approach (CRA) in the Treatment of Cannabis Users
A study testing Community Reinforcement Approach in people with Cannabis Dependence, run by International Islamic University, Islamabad at 2 sites in Pakistan.
Trial summary
Substance abuse is not a new phenomenon in Pakistan. Its prevalence is increasing day by day due to multi-factorial reasons including psychological, cultural, biological, environmental, social and personal factors. Recent statistics shows an alarming increase in the use of substance. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Cannabis Dependence
- What is being tested?
- Community Reinforcement Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesPakistan
- Study dates
- 18 Aug 2019to 21 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-30.
- Current, regular cannabis use, defined as the use of any cannabis product at least twice per week over the course of the past 12 months.
- Participant able to provide informed consent and willing to participate in the study.
Who cannot join
- ICD-11 dependence (in the previous 12 months) on alcohol or any other illicit drug (apart from cannabis) with symptoms of withdrawal, tolerance or craving.
- Current use of opiate substitution or sedative-hypnotic medication.
- Having been treated for cannabis use problems with any other treatment within the previous three months.
- Participant with lifetime psychotic disorder.
- Participants with moderate, severe and extremely severe scores on (DASS-21) will be excluded. Severe learning disability or a pervasive developmental disorder.
- Signs of severe non-cannabis-related intoxication.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Psychological Services Clinic, Medical Center, International Islamic University
Islamabad, Federal Capital, 44000
Research Office, Department of Psychology, International Islamic University Islamabad
Islamabad, Federal, 46000
About this study
Official title: A Randomized Controlled Trial (RCT) to Asses the Efficacy of Community Reinforcement Approach (CRA) in the Treatment of Cannabis Users
Substance abuse is not a new phenomenon in Pakistan. Its prevalence is increasing day by day due to multi-factorial reasons including psychological, cultural, biological, environmental, social and personal factors. Recent statistics shows an alarming increase in the use of substance. The last survey conducted indicates there are 3.6 million substance users in Pakistan and 3.6 percent among them are cannabis users. Furthermore, cannabis is found to be the most prevalent abused drug with adverse impact on the mental health among university students in Pakistan. However, there is a dearth of literature which could indicate a well-established treatment policy with proven efficacy model available in Pakistan. This study aims to investigate the efficacy of Community Reinforcement Approach (CRA) as evidence based remedy for Cannabis Users. The study is designed in a Randomized Controlled Trial (RCT) consisting of groups: Active Treatment (AT; with nine sessions of CRA intervention) and Treatment as Usual (TAU; routine treatment). After screening and baseline, participants will be assigned to the either Active Treatment group or Treatment As Usual group. Participants in both groups will be assessed on completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up). The primary outcome measure will be the frequency of usage, abstinence period and quantity of cannabis by using Timeline Follow Back Interview. The duration of the study is two and half years
- Conditions
- Cannabis Dependence
- Being tested
- Community Reinforcement Approach
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Reinforcement ApproachBehavioural
Community Reinforcement Approach (CRA) as an intervention consisting of nine sessions (each session consists of 45-minutes). Treatment is primarily based upon the guidelines by Robert Meyers and William Miller (2001). The techniques included in the sessions are functional analysis, sobriety sampling, behavioral skills, and relapse prevention techniques. The first three sessions of the intervention are based upon rapport building, induction of the rationale of CRA and Functional analysis of usage and non-usage behavior.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Group | Experimental | Community Reinforcement Approach (CRA) as an intervention consisting of nine sessions (each session consists of 45-minutes). Treatment is primarily based upon the guidelines by Robert Meyers and William Miller (2001). The techniques included in the sessions are functional analysis, sobriety sampling, behavioral skills, and relapse prevention techniques. Receives: Behavioral: Community Reinforcement Approach |
| Treatment As Usual Group | No intervention | CRA comprising of nine sessions will not be provided to this group. However, patients who will be already receiving treatment from any psychiatric or some other rehabilitation facility will be advised to continue their routine treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Line Follow-Back Interview (Assessing Change)
In order to gather additional information about the frequency, patterns, mode and quantity of cannabis use, we will use the Time Line Follow-Back Interview (TLFB; Sobell \& Sobell, 1992) as modified by the Marijuana Treatment Project Research Group, 2004, at baseline, prior to each therapy session, at post-treatment as well as at the follow-up assessments.
Measured: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
The Severity of Dependence Scale (Assessing Change)
The Severity of Dependence Scale (SDS; Gossop, Darke, Griffiths, Hando, Powis, Hall, \& Strang, 1995) will used to measure the degree of physical dependence the cannabis users experienced as well as the psychological components of their dependence. The scale will be used both at the time of screening and follow-ups.
Measured: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
Secondary outcomes (2)
Depression Stress and Anxiety Questionnaire
Depression Stress and Anxiety Questionnaire (Lovibond \& Lovibond, 1995) will be used to measure depression, anxiety and stress in the participants. It is 21 item scales with 4 point rating (0-3). This scale will be used at the time of screening and follow-ups. Participants score falling in the category of severe to extremely severe will be excluded from the research at the time of screening.
Measured: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
EQ-5D-5L
EQ-5D-5L (EuroQol, 1990) will be used to measure participant's health related quality of life across five domains i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression on 5 levels. It also include visual analogue scale on which patient has report perceived health status on 0-100 grading.
Measured: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start18 Aug 2019
- Primary completion30 Jul 2021 (estimated)
- Study completion21 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Islamic University, Islamabad
- Sponsor type
- University, hospital or other
- Collaborators
- Pakistan Institute of Living and Learning
- Responsible party
- Principal investigator, Muhammad Tahir Khalily, International Islamic University, Islamabad
- Investigators
- Muhammad Tahir Khalily, PhD, Principal investigator, International Islamic University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513756
- Sponsor's protocol ID
- 9048/Federal/NRPU/R&D/HEC/2017
- Acronym
- Lifecare
- Status last verified
- Jul 2021
- First submitted
- 9 Aug 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial (RCT) to Asses the Efficacy of Community Reinforcement Approach (CRA) in the Treatment of Cannabis Users
- ClinicalTrials.gov ID
- NCT04513756
- Acronym / sponsor ID
- Lifecare / 9048/Federal/NRPU/R&D/HEC/2017
- Conditions
- Cannabis Dependence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- International Islamic University, IslamabadUniversity, hospital or other
- Collaborators
- Pakistan Institute of Living and Learning
- Study start
- 18 Aug 2019 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 21 Dec 2021 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Substance abuse is not a new phenomenon in Pakistan. Its prevalence is increasing day by day due to multi-factorial reasons including psychological, cultural, biological, environmental, social and personal factors. Recent statistics shows an alarming increase in the use of substance. The last survey conducted indicates there are 3.6 million substance users in Pakistan and 3.6 percent among them are cannabis users. Furthermore, cannabis is found to be the most prevalent abused drug with adverse impact on the mental health among university students in Pakistan. However, there is a dearth of literature which could indicate a well-established treatment policy with proven efficacy model available in Pakistan. This study aims to investigate the efficacy of Community Reinforcement Approach (CRA) as evidence based remedy for Cannabis Users. The study is designed in a Randomized Controlled Trial (RCT) consisting of groups: Active Treatment (AT; with nine sessions of CRA intervention) and Treatment as Usual (TAU; routine treatment). After screening and baseline, participants will be assigned to the either Active Treatment group or Treatment As Usual group. Participants in both groups will be assessed on completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up). The primary outcome measure will be the frequency of usage, abstinence period and quantity of cannabis by using Timeline Follow Back Interview. The duration of the study is two and half years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Group | Experimental | Behavioral: Community Reinforcement ApproachCommunity Reinforcement Approach (CRA) as an intervention consisting of nine sessions (each session consists of 45-minutes). Treatment is primarily based upon the guidelines by Robert Meyers and William Miller (2001). The techniques included in the sessions are functional analysis, sobriety sampling, behavioral skills, and relapse prevention techniques. |
| Treatment As Usual Group | No intervention | –CRA comprising of nine sessions will not be provided to this group. However, patients who will be already receiving treatment from any psychiatric or some other rehabilitation facility will be advised to continue their routine treatment. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-30.
- Current, regular cannabis use, defined as the use of any cannabis product at least twice per week over the course of the past 12 months.
- Participant able to provide informed consent and willing to participate in the study.
Key exclusion criteria (6 listed)
- ICD-11 dependence (in the previous 12 months) on alcohol or any other illicit drug (apart from cannabis) with symptoms of withdrawal, tolerance or craving.
- Current use of opiate substitution or sedative-hypnotic medication.
- Having been treated for cannabis use problems with any other treatment within the previous three months.
- Participant with lifetime psychotic disorder.
- Participants with moderate, severe and extremely severe scores on (DASS-21) will be excluded. Severe learning disability or a pervasive developmental disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Reinforcement ApproachCommunity Reinforcement Approach (CRA) as an intervention consisting of nine sessions (each session consists of 45-minutes). Treatment is primarily based upon the guidelines by Robert Meyers and William Miller (2001). The techniques included in the sessions are functional analysis, sobriety sampling, behavioral skills, and relapse prevention techniques. The first three sessions of the intervention are based upon rapport building, induction of the rationale of CRA and Functional analysis of usage and non-usage behavior. | Behavioural | Active Treatment Group |
Primary outcome
Time Line Follow-Back Interview (Assessing Change)
Time frame: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
In order to gather additional information about the frequency, patterns, mode and quantity of cannabis use, we will use the Time Line Follow-Back Interview (TLFB; Sobell \& Sobell, 1992) as modified by the Marijuana Treatment Project Research Group, 2004, at baseline, prior to each therapy session, at post-treatment as well as at the follow-up assessments.
The Severity of Dependence Scale (Assessing Change)
Time frame: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
The Severity of Dependence Scale (SDS; Gossop, Darke, Griffiths, Hando, Powis, Hall, \& Strang, 1995) will used to measure the degree of physical dependence the cannabis users experienced as well as the psychological components of their dependence. The scale will be used both at the time of screening and follow-ups.
2 secondary outcomes
Depression Stress and Anxiety Questionnaire
Time frame: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
EQ-5D-5L
Time frame: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Tahir Khalily, PhD principal investigator
International Islamic University, Islamabad
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Reinforcement Approach in people with Cannabis Dependence, run by International Islamic University, Islamabad at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Line Follow-Back Interview (Assessing Change) (time frame: Participants in both groups will be assessed on baseline, completion of third month after randomization (Outcome assessment), six months after randomization (first follow-up), and finally ninth months after randomization (second follow up).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.