An interventional study of Community Reinforcement Approach in Cannabis Dependence, sponsored by International Islamic University, Islamabad. Status unknown at 2 sites in Pakistan. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2021-07-21.
Sponsored by International Islamic University, Islamabad · Not applicable, Interventional, and Treatment
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
188 studies on the registry are indexed under Marijuana Abuse; 26 are open to participants now.
This study's planned enrollment of 120 is above the median of 51 across 160 interventional studies indexed under Marijuana Abuse.
Browse Marijuana Abuse studies →International Islamic University, Islamabad is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Compared within Marijuana Abuse, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Community Reinforcement Approach
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.
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.
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.
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 (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.
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).
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.
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
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.
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).
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
International Islamic University, Islamabad